BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
Report
- Report Number
- 2021710-2016-03160
- Event Type
- Malfunction
- Date Received
- February 16, 2016
- Date of Event
- February 27, 2014
- Report Date
- December 31, 2016
- Manufacturer
- CAREFUSION
- Product Code
- BZR
- PMA / PMN Number
- K973646
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS ESUBMISSION IS BEING CREATED TO REPORT ASR E2016002 FOR PRO CODE BZR TO THE FDA.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED 4 BALANCE BLOCKS. FA EXAMINED THE RECEIVED BLOCKS. 2 DO NOT HAVE THE RECESS AND 2 HAD THE RECESS. THE NO RECESS BLOCKS WERE FROM THE FIRST RUN OF BLOCKS FROM 1995. THE BLOCKS WERE NOT MADE TO PRINT. THE 4 BALANCE BLOCKS WERE SCRAPPED.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT. THE ISSUE WAS CORRECTED BY REPLACING THE BALANCE BLOCKS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT. THE ISSUE WAS CORRECTED BY REPLACING THE BALANCE BLOCKS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. CAREFUSION REFERENCE NUMBER #: (B)(4). CORRECTED DATA: F10 SHOULD BE MOVED TO H10 AND CHANGED TO DEVICE CODE: 2913. PATIENT CODE: 3190. RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION'S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS THAT THE COMPONENT HAD CORRODED CONNECTOR CABLES THAT CAN CAUSE THE OVERLAY TO MALFUNCTION. THE CONNECTOR CABLES WERE NO LONGER MAKING A CONNECTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. CAREFUSION REFERENCE NUMBER #: (B)(4). CORRECTED DATA: F10 SHOULD BE MOVED TO H10 AND CHANGED TO PATIENT CODE: 3190. DEVICE CODE: 1183. DEVICE EVALUATION: D10, G4, H2, H3, H6, H10. RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THEY FOUND THAT THE CONNECTOR CABLES WERE CORRODED AND WERE NO LONGER MAKING A CONNECTION. CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995 AND DO NOT HAVE THE RECESS. THE RECESS WAS ADDED TO OBVIATE FLOW PATH OBSTRUCTION. THE BALANCE BLOCKS WERE SCRAPPED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. CAREFUSION REFERENCE NUMBER #: (B)(4). CORRECTED DATA: F10 SHOULD BE MOVED TO H10 AND CHANGED TO PATIENT CODE: 3190. DEVICE CODE: 1183. RESULTS OF INVESTIGATION: THE SUSPECT BLENDER COMPONENT WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS THAT THE COMPONENT HAD CORRODED CONNECTOR CABLES THAT CAN CAUSE THE CONTROL OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT. THE ISSUE WAS CORRECTED BY REPLACING THE BALANCE BLOCKS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER CMP147299 FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT. THE ISSUE WAS CORRECTED BY REPLACING THE BALANCE BLOCKS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. CAREFUSION REFERENCE NUMBER #: (B)(4). CORRECTED DATA: F10 SHOULD BE MOVED TO H10 AND CHANGED TO PATIENT CODE: 3190 AND DEVICE CODE: 2591. RESULTS OF INVESTIGATION: THE BLENDER UNIT WAS RETURNED TO CAREFUSION'S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A DEFECTIVE OXYGEN SENSOR CABLE. THEY FOUND THAT THE RED WIRE IN THE OXYGEN SENSOR CABLE WAS BROKEN AND READ AS AN OPEN CIRCUIT.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. CAREFUSION REFERENCE NUMBER #: (B)(4). CORRECTED DATA: F10 SHOULD BE MOVED TO H10 AND CHANGED TO PATIENT CODE: 3190 AND DEVICE CODE: 2913. RESULTS OF INVESTIGATION: THE UNIT WAS RETURNED TO CAREFUSION¿S FACTORY SERVICE. THEY ISOLATED THE ISSUE TO THE OVERLAY PAD. THE OVERLAY PAD WAS SENT TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THEY FOUND THAT THE CONNECTOR CABLES WERE CORRODED AND WERE NO LONGER MAKING A CONNECTION. CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995 AND DO NOT HAVE THE RECESS. THE RECESS WAS ADDED TO OBVIATE FLOW PATH OBSTRUCTION. THE BALANCE BLOCKS WERE SCRAPPED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. CAREFUSION REFERENCE NUMBER #: (B)(4). CORRECTED DATA: F10 SHOULD BE MOVED TO H10 AND CHANGED TO DEVICE CODE: 2913. PATIENT CODE: 3190. DEVICE EVALUATION: D10, G4, H2, H3, H6, H10. RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE COMPONENT HAD CORRODED CONNECTOR CABLES. THE CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. CAREFUSION REFERENCE NUMBER #: (B)(4). DEVICE CODE: 2913 PATIENT CODE: 3190 DEVICE EVALUATION: D10, G4, H2, H3, H6, H10. RESULTS OF INVESTIGATION: THE CONTROL OVERLAY WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE CONNECTOR CABLES WERE FOUND TO BE CORRODED AND WERE NO LONGER MAKING A CONNECTION. THE CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USED CLEANING PRODUCTS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. CAREFUSION REFERENCE NUMBER #: (B)(4). DEVICE CODE: 2913 PATIENT CODE: 3190. DEVICE EVALUATION: D10, G4, H2, H3, H6, H10. RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THEY FOUND THAT THE CONNECTOR CABLES WERE CORRODED AND WERE NO LONGER MAKING A CONNECTION. CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
CFN - OTHER THIS COMPLAINT WAS OPENED FOR SUBMISSION OF ASR E2016002 FOLLOWING TWO YEAR RETROSPECTIVE REVIEW OF (B)(6) COMPLAINTS. DUE TO A PILGRIM UPGRADE, THE NEW DB HAD TO BE USED TO SUBMIT THE EMDR.
THE CUSTOMER INDICATED HARD TO CALIBRATE BLENDER AFTER OVERHAUL. HAS OLD TYPE BLENDER BLOCKS. THE BLENDER BLOCKS WERE REPLACED.
THE CUSTOMER INDICATED BLENDER WILL NOT CALIBRATE, HAS OLDER UN-NOTCHED BALANCE BLOCKS. REPLACEMENT BALANCE BLOCKS WERE SENT TO THE CUSTOMER.
THE CUSTOMER INDICATED THE UNIT WAS OVERHAULED AND DURING THE PERFORMANCE VERIFICATION UNIT AT 21% AND 100% SETTING HAVE A NO FLOW ISSUE. REPLACEMENT BALANCE BLOCKS WERE SENT TO THE CUSTOMER.
THE CUSTOMER REPORTED THAT THE SENTRY BLENDER KEYPAD WAS NOT FUNCTIONING. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER REPORTED THAT THEY HAD A PROBLEM WITH THE SENTRY BLENDER DISPLAY MEMBRANE PANEL. THE UNLOCK MEMBRANE SWITCH DOES NOT WORK. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER INDICATED THEY ARE SENDING IN 4 BLOCKS FROM BLENDER, WITHOUT RECESS MACHINED IS CAUSING FLOW TO FLUCTUATE UP AND DOWN. THE CUSTOMER WAS SHIPPED REPLACEMENT BALANCE BLOCKS.
THE CUSTOMER REPORTED THAT THE FRONT PANEL ON THE SENTRY BLENDER WAS NOT WORKING; IT WAS UNRESPONSIVE TO ANY INPUT. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER INDICATED THE UNIT WAS OVERHAULED AND DURING PERFORMANCE VERIFICATION UNIT AT 21% AND 100% SETTING HAVE A NO FLOW ISSUE. REPLACEMENT BALANCE BLOCKS WERE SENT TO THE CUSTOMER.
THE CUSTOMER INDICATED HARD TO CALIBRATE BLENDER AFTER O/H. HAS OLD TYPE BLENDER BLOCKS. THE BLENDER BLOCKS WERE REPLACED.
THE CUSTOMER REPORTED THAT THE "ATTACH SENSOR" MESSAGE CAME AND WENT INTERMITTENTLY. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH THE SENTRY BLENDER DISPLAY MEMBRANE PANEL. THE UNLOCK MEMBRANE SWITCH DID NOT WORK. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER INDICATED HARD TO CALIBRATE BLENDER AFTER AN OVERHAUL.
THE CUSTOMER REPORTED THAT THE SENTRY BLENDER KEYPAD WAS NOT WORKING. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER REPORTED THAT THE DOWN ARROW BUTTON WAS NOT WORKING. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER REPORTED THAT THE KEYPAD WAS STUCK. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO (B)(4) MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR.(B)(4). RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE COMPONENT HAD CORRODED CONNECTOR CABLES AND WERE NO LONGER MAKING A CONNECTION. THE CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995 AND DO NOT HAVE THE RECESS. THE RECESS WAS ADDED TO OBVIATE FLOW PATH OBSTRUCTION. THE BALANCE BLOCKS WERE SCRAPPED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO (B)(4). REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. (B)(4). RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION'S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THEY FOUND THAT THE CONNECTOR CABLES WERE CORRODED AND WERE NO LONGER MAKING A CONNECTION. THE CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR (B)(4) REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR E2016002 REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR (B)(4) REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT.
ON (B)(6) 2016 A CORRECTION TO STATEMENT IN WAS IDENTIFIED TO BE NEEDED. "THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR." WAS NOT APPLICABLE TO THIS REPORT AND SHOULD BE REPLACED WITH: "THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT." "CAREFUSION REFERENCE NUMBER #: (B)(4)" SHOULD BE REMOVED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO (B)(4). REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. (B)(4). RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THEY FOUND THAT THE CONNECTOR CABLES WERE CORRODED AND WERE NO LONGER MAKING A CONNECTION. CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. (B)(4). RESULTS OF INVESTIGATION: THE OVERLAY CONTROL PANEL WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS THAT THE COMPONENT HAD CORRODED CONNECTOR CABLES THAT CAN CAUSE THE CONTROL OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR (B)(4) REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE ASR (B)(4) REPORT. REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THE FAILURE WAS DUE TO THE BALANCE BLOCKS; THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995. THE BALANCE BLOCKS WERE NOT MADE TO PRINT.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO (B)(4). REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT. RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THEY FOUND THAT THE CONNECTOR CABLES WERE CORRODED AND WERE NO LONGER MAKING A CONNECTION. CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
(B)(4). (B)(4). RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS IDENTIFIED TO BE CORRODED CABLES THAT CAN CAUSE THE CONTROL OVERLAY TO MALFUNCTION. THIS ISSUE WAS TRACED TO BE RELATED TO THE END USER'S CLEANING PRODUCTS.
THIS RECORD WAS CREATED FOR THE PURPOSE OF SUBMITTING THE SUPPLEMENTAL MDR TO THE (B)(4) REPORT. (B)(4) FOR FULL DETAILS OF THE COMPLAINT. FAILURE ANALYSIS (FA) LAB RECEIVED AND EVALUATED THE ALLEGED FAULTY BALANCE BLOCKS AND DETERMINED THEY ARE FROM THE FIRST RUN OF BLOCKS THAT WERE MADE IN 1995 AND DO NOT HAVE THE RECESS. THE RECESS WAS ADDED TO OBVIATE FLOW PATH OBSTRUCTION. THE BALANCE BLOCKS WERE SCRAPPED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR E2016002, UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR E2016002 MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR. (B)(4). RESULTS OF INVESTIGATION: THE KEYPAD OVERLAY WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE COMPONENT HAD CONNECTOR CABLES THAT WERE CORRODED AND WERE NO LONGER MAKING A CONNECTION. THE CORRODED CABLES CAN CAUSE THE OVERLAY TO MALFUNCTION. THE PROBLEM WAS TRACED TO END USER CLEANING PRODUCTS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4), UNDER REPORT NUMBER 2021710-2016-03160. THIS SUPPLEMENTAL REPORT IS BEING COMPLETED WITH RESPECT TO AN ADDITIONAL DEVICE EVALUATION FOR CAREFUSION REFERENCE NUMBER #: (B)(4). RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE DETERMINED TO BE CORRODED CABLES THAT CAUSED THE CONTROL OVERLAY TO MALFUNCTION. THIS PROBLEM WAS TRACED TO THE END USER'S CLEANING PRODUCTS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4), UNDER REPORT NUMBER 2021710-2016-03160. THIS SUPPLEMENTAL REPORT IS BEING COMPLETED WITH RESPECT TO AN ADDITIONAL DEVICE EVALUATION FOR CAREFUSION REFERENCE NUMBER #: (B)(4) RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE DETERMINED TO BE CORRODED CABLES THAT CAUSED THE CONTROL OVERLAY TO MALFUNCTION. THIS PROBLEM WAS TRACED TO THE END USER'S CLEANING PRODUCTS.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4), UNDER REPORT NUMBER 2021710-2016-03160. THIS SUPPLEMENTAL REPORT IS BEING COMPLETED WITH RESPECT TO AN ADDITIONAL DEVICE EVALUATION FOR CAREFUSION REFERENCE NUMBER #: (B)(4). RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS IDENTIFIED TO BE CORRODED CABLES CAUSING THE CONTROL OVERLAY TO MALFUNCTION. THIS ISSUE HAS BEEN TRACED TO THE END USER'S CLEANING PRODUCTS.
ON SEPTEMBER 27, 2016 CORRECTIONS TO THE RESULTS AND CONCLUSION CODES WERE NOTED TO BE NEEDED IN ADDITION TO A CORRECTION.. (B)(4). STATEMENT: "THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4), UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR (B)(4) MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR." WAS NOT APPLICABLE TO THIS REPORT AND SHOULD BE REPLACED WITH: "THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4). REFERENCE PILGRIM COMPLAINT NUMBER (B)(4) FOR FULL DETAILS OF THE COMPLAINT." "CAREFUSION REFERENCE NUMBER #: (B)(4)" SHOULD BE REMOVED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4), UNDER REPORT NUMBER 2021710-2016-03160. THIS SUPPLEMENTAL REPORT IS BEING COMPLETED WITH RESPECT TO AN ADDITIONAL DEVICE EVALUATION FOR CAREFUSION REFERENCE NUMBER #: (B)(4). RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE CORRODED CABLES CAUSING THE CONTROL OVERLAY TO MALFUNCTION. THIS ISSUE WAS TRACED TO THE END USER'S CLEANING PRODUCTS.
(B)(4). "THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4), UNDER REPORT NUMBER 2021710-2016-03159. DUE TO SOFTWARE LIMITATIONS, ADDITIONAL SUPPLEMENTAL REPORTS IN REFERENCE TO ASR (B)(4) MDR'S WILL BE SUBMITTED VIA THIS CURRENT REPORT NUMBER TO PROVIDE ADDITIONAL INFORMATION AND DEVICE EVALUATIONS FOR COMPLAINTS SUBMITTED UNDER THE ASR." WAS NOT APPLICABLE TO THIS REPORT AND SHOULD BE REPLACED WITH: "THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4). (B)(4)." "CAREFUSION REFERENCE NUMBER #: (B)(4)" SHOULD BE REMOVED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO (B)(4), UNDER REPORT NUMBER 2021710-2016-03159. THIS SUPPLEMENTAL REPORT IS BEING COMPLETED WITH RESPECT TO AN ADDITIONAL DEVICE EVALUATION FOR CAREFUSION REFERENCE NUMBER #: (B)(4). RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT MICROBLENDER FOR FAILURE ANALYSIS. USE TESTING WAS PERFORMED AND THE DEVICE OPERATED AS INTENDED, MAKING AN AUDIBLE ALARM ONCE ANY OF THE GAS SOURCES WERE DISCONNECTED. THE CUSTOMER'S REPORTED ISSUE WAS UNABLE TO BE DUPLICATE AND NO FAILURE WAS DETECTED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO ASR (B)(4), UNDER REPORT NUMBER 2021710-2016-03160. THIS SUPPLEMENTAL REPORT IS BEING COMPLETED WITH RESPECT TO AN ADDITIONAL DEVICE EVALUATION FOR CAREFUSION REFERENCE NUMBER #: (B)(4). RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS IDENTIFIED TO BE DUE TO CORRODED CABLES AS A RESULT OF THE CUSTOMER'S CLEANING SOLUTION USED.
THIS SUPPLEMENTAL IS BEING SUBMITTED IN REFERENCE TO (B)(4), UNDER REPORT NUMBER 2021710-2016-03159. THIS SUPPLEMENTAL REPORT IS BEING COMPLETED WITH RESPECT TO AN ADDITIONAL DEVICE EVALUATION FOR CAREFUSION REFERENCE NUMBER #: (B)(4). RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS IDENTIFIED TO CORRODED CABLES THAT CAN CAUSE THE CONTROL OVERLAY TO MALFUNCTION WHICH WAS TRACED TO THE END USER'S CLEANING PRODUCTS.
THE CUSTOMER INDICATED THE FLOW JUMPS AROUND A LOT WHEN HE TURNS FIO2 KNOB FROM 21 TO 60 THEN TO 100. REPLACEMENT BALANCE BLOCKS WERE SENT TO THE CUSTOMER.
THE CUSTOMER REPORTED THAT THE SENTRY BLENDER KEYPAD WAS NOT FUNCTIONING. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER INDICATED HARD TO CALIBRATE BLENDER AFTER OVERHAUL. HAS OLD TYPE BLENDER BLOCKS. THE BLENDER BLOCKS WERE REPLACED.
THE CUSTOMER REPORTED THAT THE SENTRY BLENDER KEYPAD WAS NOT FUNCTIONING. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER INDICATED BLENDER NO RECESS IN DIAPHRAGM SEAT. FLOWS CEASE. REPLACEMENT BALANCE BLOCKS WERE SENT TO THE CUSTOMER.
THE CUSTOMER INDICATED AFTER ROUTINE OVERHAUL, THE BLENDER SHOWED FLUCTUATING OUTPUT FLOWS. REPLACEMENT BLOCKS WERE SENT TO THE CUSTOMER.
THE CUSTOMER INDICATED BLENDER WILL NOT CALIBRATE. IT HAS OLDER UN-NOTCHED BALANCE BLOCKS. BLOCKS REPLACED. THE CUSTOMER WAS SHIPPED REPLACEMENT BALANCE BLOCKS.
THE CUSTOMER REPORTED THAT THE KEYPAD WAS FROZEN AND THEY COULD NOT MAKE ADJUSTMENTS. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER REPORTED THAT THE SENTRY BLENDER TOUCHPAD WAS NOT RESPONDING. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER INDICATED IT IS HARD TO CALIBRATE THE BLENDER AFTER OVERHAUL. HAS OLD TYPE BLENDER BLOCKS. THE BLENDER BLOCKS WERE REPLACED.
THE CUSTOMER INDICATED IT IS HARD TO CALIBRATE THE BLENDER AFTER OVERHAUL. HAS OLD TYPE BLENDER BLOCKS. THE BLENDER BLOCKS WERE REPLACED.
THE CUSTOMER REPORTED THAT THE SENTRY BLENDER KEYPAD WAS NOT FUNCTIONING. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER REPORTED THAT THE TOUCH PAD ON THE BLENDER IS NOT RESPONDING. NO INFORMATION WAS PROVIDED REGARDING PATIENT INVOLVEMENT, IT IS CURRENTLY UNKNOWN.
THE CUSTOMER INDICATED NO RECESS FOR THE DIAPHRAGM SEATING AREA OF THE BALANCE BLOCKS, CAUSING FLOW CESSATION DURING OPERATION.
THE CUSTOMER REPORTED THAT THE SENTRY BLENDER KEYPAD HAD GONE BAD. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT.
THE CUSTOMER REPORTED THAT THE BLENDER'S KEYPAD IS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
THE CUSTOMER REPORTED THAT THE KEYPAD PORTION OF THEIR SENTRY BLENDER WAS NOT FUNCTIONING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
THE CUSTOMER REPORTED THAT THE KEYPAD ON THE SCREEN DOES NOT WORK AT ALL AND IS FROZEN. THE CUSTOMER REPORTED THAT THE BLENDER PORTION OF THE DEVICE WORKS FINE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
THE CUSTOMER REPORTED THAT THE KEYPAD IS FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
THE CUSTOMER REPORTED THAT THE BLENDER DID NOT ALARM WHEN ONE OF THE GAS SUPPLY LINES WAS DISCONNECTED. AIR FLOW CAN BE FELT THROUGH THE ALARM CAP BUT NO SOUND IS AUDIBLE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
THE CUSTOMER REPORTED THAT THE KEYPAD ON THE BLENDER'S OXYGEN MONITORING PORTION FROZE UP SO NO CHANGES COULD BE MADE. THE CUSTOMER ALSO REPORTED THAT WHEN THIS OCCURRED, THE BLENDER DID NOT ALARM WHEN THE ALARM SETTINGS WERE BREACHED. THE DEVICE WAS IN USE WITH A PATIENT AT THE TIME AND THERE WAS NO HARM OR INJURY.
THE CUSTOMER REPORTED THAT THEIR BLENDER HAS A BAD OVERLAY FOR THEIR BUTTONS. THE "LOCKED/UNLOCKED" BUTTON IS NOT RESPONDING. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING PATIENT INVOLVEMENT, IT IS CURRENTLY UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96071 | BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER | MIXER, BREATHING GASES, ANESTHESIA INHALATION | BZR | CAREFUSION | SENTRY BLENDER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |