HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-00432
- Event Type
- Malfunction
- Date Received
- January 30, 2018
- Date of Event
- January 2, 2018
- Report Date
- June 20, 2019
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: THE CONTROLLER WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CORRECTIONS: D10, H10 PRODUCT EVENT SUMMARY: THE CONTROLLER AND SIX BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4), AS WELL AS SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). ANALYSIS OF THE EVENT LOG FILE REVEALED TWO (2) CONTROLLER POWER UPS WITH THEIR ASSOCIATED MOTOR STARTS ON 23/DEC/2017 AT 19:11:21 AND ON 02/JAN/2018 AT 21:43:07. SEVERAL MOMENTARY DISCONNECTIONS WERE RECORDED LEADING UP TO THE LOSSES OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR 14 SECONDS AND 12 SECONDS, RESPECTIVELY. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. A POSSIBLE ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS:(B)(4). THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CORRECTION: D10. PRODUCT EVENT SUMMARY: THE CONTROLLER (B)(4) IS NOT AVAILABLE FOR EVALUATION. SIX BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). ADDITIONALLY, POWER SWITCHING DUE TO COMMUNICATION ERRORS WERE RECORDED INVOLVING (B)(4). LOG FILES ANALYSIS REVEALED THREE (2) CONTROLLER POWER-UPS WITH THEIR ASSOCIATED MOTOR STARTS. MOMENTARY DISCONNECTIONS WERE RECORDED LEADING UP TO THE FIRST LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR 14 SECONDS AND 12 SECONDS; RESPECTIVELY. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON BOTH POWER SOURCES. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. ADDITIONAL PRODUCTS: BATTERY (B)(4). H6 FDA CONCLUSION CODE(S): 4307 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL PRODUCTS: BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-31 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS CONFIRMED. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-31 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS CONFIRMED. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-31 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS CONFIRMED. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-31 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS CONFIRMED. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-31 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS CONFIRMED. INVESTIGATION IS ONGOING. BATTERY (B)(4). D10: YES, RETURN DATE: 2018-01-31 H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT WAS CONFIRMED. INVESTIGATION IS ONGOING. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30, UDI# ASKU, MFG DATE: 2016-06-30, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30, UDI #: ASKU, (B)(4), MFG DATE: 2016-06-30, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30, UDI #: ASKU, MFG DATE: 2016-06-30, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30, UDI #: ASKU, MFG DATE: 2016-06-30, (B)(4), HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30, UDI #: ASKU, MFG DATE: 2016-06-30, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30, UDI #: ASKU, MFG DATE: 2016-06-30. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE CONTROLLER WAS POWER SWITCHING BEFORE THE BATTERIES HAD DEPLETED TO LESS THAN TWENTY-FIVE PERCENT (25%) CHARGE CAPACITY. IT WAS ALSO REPORTED THAT CONTROLLER POWER UP EVENTS OCCURRED. THE CONTROLLER AND ASSOCIATED BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 70489 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1420-MCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | (B)(4).| MCS UNKNOWN VAD |