CS100
Report
- Report Number
- 2249723-2019-01683
- Event Type
- Malfunction
- Date Received
- October 17, 2019
- Date of Event
- September 25, 2019
- Report Date
- March 19, 2020
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
THE SUSPECTED OOB MOTOR CONTROL BOARD HAS BEEN RECEIVED TO GETINGE'S NATIONAL REPAIR CENTER (NRC) FOR FAILURE INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT WHEN THE INVESTIGATION HAS BEEN PERFORMED.
REPAIRS ON THE IABP WERE PERFORMED AND DONE BY A GETINGE AUTHORIZED DEALER'S FSE, A GETINGE FSE LATER REPORTED THAT THE IABP HAS BEEN RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE SUSPECTED FAULTY OOB PART IS GOING TO BE RETURNED TO GETINGE'S NATIONAL REPAIR CENTER (NRC) FOR FAILURE INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED.
THE SUPPLIER VERIFIED THE REPORTED FAILURE AND RETURNED THE MOTOR CONTROL BOARD TO THE GETINGE'S NATIONAL REPAIR CENTER (NRC). THE SUPPLIER INDICATED THAT THESE WERE THE RESULTS OF THEIR TESTING: ELECTRICAL TEST RESULTS FOR 18 00166 50 INDICATED THE REGULATOR AND (2) OF THE (6) MOSFETS WERE SHORTING. RMA TECH REPLACED (6) MOSFETS, REGULATOR AND DRIVE TRANSISTORS AND TESTED. SUBSEQUENT TESTS RESULTED IN THE MOSFETS SHORTING OUT. THE SUPPLIER THEN TOOK THE FOLLOWING ACTIONS TO CORRECT THE FAILURE: DUE TO THE CONTINUOUS SHORTING OF THE MOSFETS COMMON TO 18 0016 50, THIS UNIT WAS REPLACED WITH A FULLY TESTED AND VERIFIED MOTOR CONTROLLER. THE ORIGINAL SERIAL NUMBER WAS TRANSFERRED TO THIS NEW UNIT. THE REASON FOR THE MOSFETS SHORTING COULD NOT BE DETERMINED WITH THE EXISTING EQUIPMENT. THE SUPPLIER DID NOT RETURN THE ORIGINAL BOARD TO THE NRC SINCE THE SUPPLIER REMOVED THE SERIAL NUMBER FROM THE ORIGINAL BOARD AND PLACED IT ON A NEW BOARD. THE NRC TECHNICIAN INSTALLED THE BOARD (NOT ORIGINAL BOARD THAT WAS SENT BACK TO THE SUPPLIER) INTO A CS100 TEST FIXTURE AND THE BOARD TESTED TO FACTORY SPECIFICATIONS PER CS100 SERVICE MANUAL. THE BOARD PASSED TESTING AND WILL BE SCRAPPED AND RETAINED IN THE NRC. UPDATED FIELDS: B4, G4, G7, H2, H6 (EVALUATION RESULT AND CONCLUSION CODES), H10.
THE SUSPECTED FAULTY OOB MOTOR CONTROL BOARD WAS INSPECTED BY A SENIOR REPAIR TECHNICIAN AND NO VISUAL DAMAGE WAS OBSERVED. THE TECHNICIAN THEN INSTALLED THE MOTOR CONTROL BOARD INTO CS100 TEST FIXTURE AND IT TESTED TO FACTORY SPECIFICATIONS PER CS100 SERVICE MANUAL AND IT FAILED TESTING. THE IABP HAD NO DISPLAY AND GENERATED A FAILURE ALARM. BLOWS BULK FUSE ON POWER SUPPLY. THE MOTOR CONTROL BOARD IS BEING SENT TO THE SUPPLIER FOR FAILURE ANALYSIS AS PER PROCEDURE.
A GETINGE FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHEN A GETINGE AUTHORIZED DEALER'S FSE TURNED ON A NEW CS100 INTRA-AORTIC BALLOON PUMP (IABP), IT WOULD DETECT A LONG BEEP AND THE SCREEN WOULD NOT LIGHT UP. THIS IS AN OUT-OF-BOX FAILURE (OOB). THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.
A GETINGE FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHEN A GETINGE AUTHORIZED DEALER'S FSE TURNED ON A NEW CS100 INTRA-AORTIC BALLOON PUMP (IABP), IT WOULD DETECT A LONG BEEP AND THE SCREEN WOULD NOT LIGHT UP. THIS IS AN OUT-OF-BOX FAILURE (OOB). THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.
A GETINGE FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHEN A GETINGE AUTHORIZED DEALER'S FSE TURNED ON A NEW CS100 INTRA-AORTIC BALLOON PUMP (IABP), IT WOULD DETECT A LONG BEEP AND THE SCREEN WOULD NOT LIGHT UP. THIS IS AN OUT-OF-BOX FAILURE (OOB). THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.
A GETINGE FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHEN A GETINGE AUTHORIZED DEALER'S FSE TURNED ON A NEW CS100 INTRA-AORTIC BALLOON PUMP (IABP), IT WOULD DETECT A LONG BEEP AND THE SCREEN WOULD NOT LIGHT UP. THIS IS AN OUT-OF-BOX FAILURE (OOB). THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.
THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS REVIEWED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE NOTED.AFTER THE IABP WAS TESTED, IT WAS FOUND THAT THE VOLTAGE OUTPUT OF THE POWER MODULE 28V WAS 0V, THE FUSE WAS DAMAGED AND THE MOTOR DRIVE BOARD WAS REPLACED. AFTER THE FUSE WAS REPLACED, THE FAULT WAS REMOVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED.
IT WAS REPORTED THAT A NEW CS100 INTRA-AORTIC BALLOON PUMP (IABP) DETECTS A LONG BEEP WHEN TURNED ON AND THE SCREEN DOES NOT LIGHT UP. THERE WAS NO PATIENT INVOLVEMENT, THUS NO ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 995367 | CS100 | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |