THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP 103696Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00813024010630), received between Jun 25, 2018 and Oct 9, 2025 — classified as 7 deaths, 11 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (22 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2025Electrical /Electronic Property Problem; Complete Loss of Power; Electrical /Electronic Property Problem; Complete Loss of Power

  IT WAS ADDITIONALLY REPORTED THAT A PUMP SHUTDOWN WITHOUT THE TYPICAL INCREASE IN PUMP POWER WAS ALSO RECORDED, MAKING DRIVELINE DAMAGE A LOW SUSPICION BUT NOT COMPLETELY RULED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23262158 ↗
• MalfunctionMay 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS RUSHED TO THE HOSPITAL IN THE STATE OF CARDIAC ARREST. DEATH WAS CONFIRMED AT THE HOSPITAL. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS FOUND IN A STATE OF CARDIAC ARREST AND EMERGENCY SERVICES WAS CALLED AFTER THE "BATTERY WAS REPLACED". IT WAS NOTED THAT THE CAUSE OF DEATH WAS VENTRICULAR ASSIST DEVICE FAILURE, IT WAS SUSPECTED THAT THE SYSTEM CONTROLLER MALFUNCTIONED AS THE DEVICE DID NOT OPERATE EVEN AFTER CONNECTING A CHARGED BATTERY. IT WAS UNKNOWN IF THE DEVICE OPERATED AS EXPECTED AND THE PUMP WOULD NOT RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953908 ↗
• MalfunctionMar 14, 2025Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE PUMP OFFS AND LOW VOLTAGE ALARMS. LOG FILES WERE SENT FOR REVIEW, AND THE DATA SHOWED SPEED REDUCTION AND PUMP STOPPED EVENTS ON 25JAN2025. THESE ISSUES ONLY APPEAR TO BE OCCURRING WHILE THE VENTRICULAR ASSIST DEVICE (VAD) WAS CONNECTED TO POWER MODULE POWER. THIS TYPE OF BEHAVIOR HAS BEEN LINKED TO POTENTIAL ISSUES WITH THE PERCUTANEOUS LEAD. THE PATIENT EXPERIENCED SHORTNESS OF BREATH FROM THE PUMP OFFS THAT WAS TREATED WITH BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP). THE PATIENT WAS BEING MONITORED IN HOUSE, AND ABBOTT ENGINEERS WOULD PERFORM A DRIVELINE REPAIR, AS THE PATIENT WAS SUSPECTED TO HAVE A SHORT TO SHIELD. ON (B)(6) 2025, TECH SERVICES ARRIVED ONSITE FOR DRIVELINE EVALUATION AND REPAIR AND PERFORMED A DRIVELINE REPAIR 2" INCHES FROM THE EXIT SITE. POST REPAIR, THE PATIENT WAS TETHERED ON GROUNDED PATIENT CABLE WITHOUT ISSUE. THE SYSTEM CONTROLLER WAS EXCHANGED AS PART OF EQUIPMENT REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609292 ↗
• MalfunctionFeb 19, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT INVESTIGATION OF THE RETURNED SYSTEM CONTROLLER REVEALED CONTAMINATION OF A FOREIGN MATERIAL AROUND THE DRIVELINE RELEASE BUTTON AND LATCH AND WIRE FATIGUE WITHIN BOTH POWER CABLES THAT DID NOT AFFECT THE SYSTEM CONTROLLER¿S FUNCTIONALITY THROUGHOUT TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413741 ↗
• MalfunctionJan 20, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT WAS NOTED TO HAVE MULTIPLE NO EXTERNAL POWER, LOW FLOW ALARMS, LOW SPEED ADVISORY, PUMP OFF, AND DRIVELINE DISCONNECT ALARMS ON VARIOUS DATES. LOG FILES WERE SENT FOR REVIEW. THE LOG FILE APPEARED TO INDICATE THAT THE SYSTEM CONTROLLER HAD BEEN IN USE SINCE (B)(6) 2024. FOLLOWING THE INITIAL CONNECTION ALARMS, THE PUMP RESUMED THE PROGRAMMED SET SPEED. CLUSTERS OF LOW FLOW HAZARD EVENTS WERE RECORDED BETWEEN 14DEC2024-29DEC2024. THESE FLOW READINGS DID NOT APPEAR TO BE THE RESULT OF ANY EXTERNAL EQUIPMENT MALFUNCTION. THE CONTROLLER APPEARED TO HAVE LOST EXTERNAL POWER ON (B)(6) 2024 WHILE UTILIZING THE MOBILE POWER UNIT (MPU). THE CONTROLLER DID SWITCH APPROPRIATELY TO THE EXTERNAL BACKUP BATTERY (EBB) WHEN EXTERNAL POWER WAS LOST. THE ALARMS RESOLVED ONCE EXTERNAL POWER WAS RESTORED. ADDITIONALLY, THE DATA THAT WAS REVIEWED SHOWED A TRANSIENT POWER/FLOW ELEVATION ON (B)(6) 2024. THE ELEVATION DID NOT APPEAR TO BE A RESULT OF ANY EQUIPMENT MALFUNCTION AND WAS MOST LIKELY PATIENT RELATED. BASED ON THE DATA VISIBLE THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT WAS OPERATING AS INTENDED ELECTRONICALLY AND MECHANICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21192611 ↗
• MalfunctionJan 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS NOTED TO HAVE MULTIPLE NO EXTERNAL POWER, LOW FLOW ALARMS, LOW SPEED ADVISORY, PUMP OFF, AND DRIVELINE DISCONNECT ALARMS ON VARIOUS DATES. LOG FILES WERE SENT FOR REVIEW. THE LOG FILE APPEARED TO INDICATE THAT THE SYSTEM CONTROLLER HAD BEEN IN USE SINCE 11DEC2024. FOLLOWING THE INITIAL CONNECTION ALARMS, THE PUMP RESUMED THE PROGRAMMED SET SPEED. CLUSTERS OF LOW FLOW HAZARD EVENTS WERE RECORDED BETWEEN (B)(6) 2024. THESE FLOW READINGS DID NOT APPEAR TO BE THE RESULT OF ANY EXTERNAL EQUIPMENT MALFUNCTION. THE CONTROLLER APPEARED TO HAVE LOST EXTERNAL POWER ON (B)(6) 2024 WHILE UTILIZING THE MOBILE POWER UNIT (MPU). THE CONTROLLER DID SWITCH APPROPRIATELY TO THE EXTERNAL BACKUP BATTERY (EBB) WHEN EXTERNAL POWER WAS LOST. THE ALARMS RESOLVED ONCE EXTERNAL POWER WAS RESTORED. ADDITIONALLY, THE DATA THAT WAS REVIEWED SHOWED A TRANSIENT POWER/FLOW ELEVATION ON (B)(6) 2024. THE ELEVATION DID NOT APPEAR TO BE A RESULT OF ANY EQUIPMENT MALFUNCTION AND WAS MOST LIKELY PATIENT RELATED. BASED ON THE DATA VISIBLE THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT WAS OPERATING AS INTENDED ELECTRONICALLY AND MECHANICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21192408 ↗
• MalfunctionDec 6, 2024Disconnection; Electrical Power Problem; Disconnection; Electrical Power Problem

  IT WAS REPORTED THAT PATIENT RECEIVED A PUMP REPLACEMENT FROM HEARTMATE II (HMII) TO HEARTMATE 3 (HM3) DUE TO SUSPECTED DRIVELINE DISCONNECTION. SPEED WAS DECREASED AND HMII BLOOD PUMP STOPPED ON (B)(6)2024. IT THEN WAS REPLACED THE PUMP WITH HM3 WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OPERATING. THERE WAS HEMODYNAMIC FAILURE DUE TO THE PUMP STOP. THE PATIENT REMAINED HOSPITALIZED. THE REASON OF DRIVELINE DISCONNECT COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871845 ↗
• MalfunctionNov 13, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE HEARTMATE II SYSTEM CONTROLLER WAS CHANGED ON 23AUG2024 DUE TO THE GREEN CIRCULAR LIGHT NOT LIGHTING UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678045 ↗
• MalfunctionOct 6, 2024Disconnection; Insufficient Device Problem Information; Disconnection; Insufficient Device Problem Information

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED MAINLY ROUTINE EVENTS UNTIL 0930 ON 11SEP2024 WHEN THE PATIENT WAS CHANGING POWER SOURCES FROM MOBILE POWER UNIT (MPU) TO BATTERY AND IT APPEARED AS THOUGH THE BLACK POWER LEAD WAS NEVER CONNECTED CAUSING CONSTANT POWER CABLE DISCONNECT EVENTS. THESE OCCURRED UNTIL THE DRIVELINE WAS DISCONNECTED AT 2114 ON (B)(6) 2024 FOR A SYSTEM CONTROLLER EXCHANGE. THE LOG FILE CAPTURED NEW SYSTEM CONTROLLER DATA STARTING AT 2114 ON (B)(6) 2024 WHICH NOTED A COUPLE LOW FLOW EVENTS AT 0726 17SEP2024 AND AT 0857 ON 11SEP2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20380193 ↗
• MalfunctionJun 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT INVESTIGATION OF THE SYSTEM CONTROLLER REVEALED INTERNAL WIRE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568098 ↗
• MalfunctionJun 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2024, A CONTINUOUS SOUND ALARM OCCURRED AT HOME, AND THE PATIENT APPARENTLY REPLACED THE SYSTEM CONTROLLER WITH A BACKUP ONE. ON (B)(6) 2024, THE PATIENT VISITED THE HOSPITAL, AND WHEN HOSPITAL STAFF CONNECTED THE CONTROLLER TO A POWER MODULE, A PUMP OFF ALARM OCCURRED. CURRENTLY THE PATIENT WAS HOSPITALIZED AND CONNECTED TO BATTERIES. THE PATIENT WAS ASYMPTOMATIC. LOG FILE REVIEW WAS REQUESTED, AND THE DATA DISPLAYED 57 LOW SPEED ADVISORY ALARMS AND 63 PUMP STOP EVENTS DURING THE ROUGHLY 2-MINUTE LENGTH OF THE LOG FILE HISTORY. SPEED DROPS WERE AS LOW AS 0 RPM. THESE EVENTS WERE FOLLOWED BY DRIVELINE DISCONNECTS WHERE THE DRIVELINE WAS DISCONNECTED FROM THE CONTROLLER INDICATIVE OF A CONTROLLER CHANGE AS MENTIONED. THIS TYPE OF BEHAVIOR HAD BEEN LINKED TO POTENTIAL ISSUES WITH THE PERCUTANEOUS LEAD. THESE ISSUES APPEARED TO BE OCCURRING WHILE THE VENTRICULAR ASSIST DEVICE (VAD) WAS CONNECTED TO BATTERIES AND/OR POWER MODULE. IT WAS COMMUNICATED ON (B)(6) 2024 THAT THE PATIENT'S PUMP WAS EXCHANGED WITH A HEARTMATE 3, AND THE PUMP AND 1 SYSTEM CONTROLLER WERE TO RETURN FOR EVALUATION. IT WAS COMMUNICATED ON 28MAY2024 THAT THE REASON FOR THE PUMP EXCHAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488072 ↗
• MalfunctionMay 8, 2024Mechanical Problem; Mechanical Problem

  THE SYSTEM CONTROLLER WAS NOT REPLACED AND WOULD NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270532 ↗
• MalfunctionApr 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE SYSTEM CONTROLLER WAS RETURNED FOLLOWING THE PATIENT'S ROUTINE HEART TRANSPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19044510 ↗
• MalfunctionMar 27, 2024Alarm Not Visible; Disconnection; Electrical Power Problem; Alarm Not Visible; Disconnection; Electrical Power Problem

  IT WAS REPORTED THAT NOTHING WAS DONE TO CAUSE AN ALARM. THE SYSTEM CONTROLLER WAS ALARMING APPROPRIATELY, AND NO ALARMS WERE REPORTED AFTER THE POWER MODULE CABLE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988359 ↗
• MalfunctionFeb 29, 2024Disconnection; Disconnection

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE DRIVELINE DISCONNECT WAS UNKNOWN. THE PATIENT HAD A SHORT-TO-SHIELD DUE TO A DAMAGE TO A LAYER OF THE DRIVELINE PECULIAR TO THE HEARTMATE II.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813136 ↗
• MalfunctionJan 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PUMP EXCHANGE AND THE SYSTEM CONTROLLER WAS EXCHANGED. RELATED REGULATORY REFERENCE REPORT MFR # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563732 ↗
• MalfunctionJan 3, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN THE WHITE CABLE WAS TOUCHED AT THE CONNECTOR BASE, AN INTERMITTENT SOUND WAS ACTIVATED. A POWER CABLE DISCONNECT ALARM WAS NOTED. THE EVENT WAS REPRODUCIBLE. THE PATIENT WAS TO VISIT THE HOSPITAL ON (B)(6) 2023 TO CHANGE THE SYSTEM CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438388 ↗
• MalfunctionOct 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MFR # 2916596-2023-07388. IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO A FALL. THE PATIENT ALSO HAD RED HEART ALARMS. DEATH WAS CONSIDERED RELATED TO THE HEARTMATE II SYSTEM CONTROLLER.

  Patient problems: Insufficient Information

  MAUDE report 18040731 ↗
• MalfunctionSep 19, 2023Disconnection; Mechanical Problem; Disconnection; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD POSSIBLE WATER DAMAGE TO THE SYSTEM CONTROLLER AND EXPERIENCED A LOT OF POWER CABLE DISCONNECTS. IT WAS NOTED THAT THE PATIENT EXPERIENCED FREQUENT LOW FLOW ALARMS WITH A NORMAL PULSATILITY INDEX (PI). THE PATIENT'S SYSTEM CONTROLLER WAS EXCHANGED AND SENT BACK FOR EVALUATION. IT WAS ALSO NOTED THAT THE PATIENT DENIED ANY SYMPTOMS AND DID NOT REPORT HEARING ANY ALARMS. LOG FILES WERE NOT COLLECTED, AND THE CAUSE OF THE ALARMS WAS NOT CONFIRMED. AS OF (B)(6) 2023 THERE HAD NOT BEEN ANY ONGOING ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17776781 ↗
• MalfunctionMay 4, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT COMPLAINED THE PUMP WAS STOPPED. THE CLINICIANS COMMENTATED THAT THE PATIENT WENT INTO CARDIAC ARREST WHILE USING BATTERIES. SEVERAL PUMP STOPS HAD ALSO OCCURRED WHILE USING THE POWER MODULE. LOG FILES CONFIRMED ONE PUMP STOP EVENT WHILE ON WALL POWER AND TWO MORE PUMP STOPS WHILE ON BATTERY POWER. IN THE MIDDLE OF THE NIGHT ON (B)(6) 2023, THE PATIENT EXPERIENCED A PUMP STOP AT HOME AND WAS TRANSPORTED TO A NEARBY HOSPITAL. THE PATIENT WAS IN A CAR DRIVEN BY THEIR HELPER WHEN THE PUMP STOP OCCURRED. THE BATTERIES AND POWER MODULE WERE EXCHANGED AND THE PUMP STOPS CONTINUED. THE CONTROLLER WAS REPLACED, BUT THE PUMP STOPS OCCURRED AGAIN SEVERAL TIMES. THE CAUSE OF THE PUMP STOP WAS UNKNOWN. THE PATIENT WAS TRANSFERRED TO THE IMPLANTING CENTER. ON ARRIVAL TO THE HOSPITAL IT WAS DISCOVERED THAT THE PATIENT HAD DEVELOPED HYPOXIC ENCEPHALOPATHY. THE LOG FILE ANALYSIS CAPTURED THREE PUMP STOP EVENTS, BUT THERE WAS ONLY 6 HOURS OF DATA RECORDED DUE TO THE RECENT CONTROLLER EXCHANGE. THE PATIENT NEVER RECOVERED. THE PATIENT PASSED AWAY ON (B)(6) 2023. THE PATIENT'S DEATH WAS THOUGHT TO POSSIBLY BE DEVICE RELATED. THE DEVICE DID NOT OPERATE AS EXPECTED. PUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872731 ↗
• MalfunctionMay 4, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT COMPLAINED THE PUMP WAS STOPPED. THE CLINICIANS COMMENTED THAT THE PATIENT WENT INTO CARDIAC ARREST WHILE USING BATTERIES. SEVERAL PUMP STOPS HAD ALSO OCCURRED WHILE USING THE POWER MODULE. LOG FILES CONFIRMED ONE PUMP STOP EVENT WHILE ON WALL POWER AND TWO MORE PUMP STOPS WHILE ON BATTERY POWER. IN THE MIDDLE OF THE NIGHT ON (B)(6) 2023, THE PATIENT EXPERIENCED A PUMP STOP AT HOME AND WAS TRANSPORTED TO A NEARBY HOSPITAL. THE PATIENT WAS IN A CAR DRIVEN BY THEIR HELPER WHEN THE PUMP STOP OCCURRED. THE BATTERIES AND POWER MODULE WERE EXCHANGED AND THE PUMP STOPS CONTINUED. THE CONTROLLER WAS REPLACED, BUT THE PUMP STOPS OCCURRED AGAIN SEVERAL TIMES. THE CAUSE OF THE PUMP STOP WAS UNKNOWN. THE PATIENT WAS TRANSFERRED TO THE IMPLANTING CENTER. ON ARRIVAL TO THE HOSPITAL IT WAS DISCOVERED THAT THE PATIENT HAD DEVELOPED HYPOXIC ENCEPHALOPATHY. THE LOG FILE ANALYSIS CAPTURED THREE PUMP STOP EVENTS, BUT THERE WAS ONLY 6 HOURS OF DATA RECORDED DUE TO THE RECENT CONTROLLER EXCHANGE. THE PATIENT NEVER RECOVERED. THE PATIENT PASSED AWAY ON (B)(6) 2023. THE PATIENT'S DEATH WAS THOUGHT TO POSSIBLY BE DEVICE RELATED. THE DEVICE DID NOT OPERATE AS EXPECTED. PUMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872621 ↗
• MalfunctionMar 24, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN THE PATIENT CHANGED POWER SOURCES, THEY HEARD A CONTINUOUS ALARM. A REVIEW OF THE LOG FILES BY TECHNICAL SERVICES FOUND POWER CABLE DISCONNECT ALARMS THAT OCCURRED WHEN THE PATIENT WAS CONNECTED TO THE POWER MODULE AND A BATTERY AT THE SAME TIME. THE ALARM RESOLVED BY ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611231 ↗
• MalfunctionMar 23, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING THE PATIENT'S HEART TRANSPLANT THE SYSTEM CONTROLLER WAS FOUND TO HAVE WIRE FATIGUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598576 ↗
• MalfunctionFeb 27, 2023No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE PATIENT HAD LOW VOLTAGE ADVISORIES WITHOUT A POWER SUPPLY REPLACEMENT. THE LOW VOLTAGE ADVISORY OCCURRED FREQUENTLY WHILE CONNECTING THE BATTERY. THE PATIENT HAS PREVIOUSLY HAD BATTERY CLIPS, POWER MODULE CABLES, AND CONTROLLERS REPLACED IN OCTOBER BUT THE LOW VOLTAGE ADVISORIES HAVE PERSISTED. PREVIOUS LOG FILE ANALYSIS SUGGESTED BATTERY CALIBRATION BUT THE BATTERY CHARGER DIDN'T SHOW CALIBRATION WHILE CHARGING. THE LOW VOLTAGE ADVISORIES WERE OCCURRING FREQUENTLY SO THE BATTERIES WERE REPLACED. IT WAS LATER STATED THAT THE LOW VOLTAGE ADVISORY ALARMS DID NOT SOUND SO THE PATIENT WAS UNAWARE OF ALARMS. ALTHOUGH IT HAD JUST BEEN AN HOUR OR TWO SINCE THE BATTERY EXCHANGE, OCCASIONAL LOW VOLTAGE ADVISORY ALARMS WERE RECORDED AGAIN. THE BATTERY CLIPS WERE REPLACED, THE CONTROLLER WAS REPLACED BUT THE ALARMS CONTINUED. ON HOSPITAL VISIT ON (B)(6) 2022 BATTERY FAILURE WAS SUSPECTED AND THE PATIENT WAS GIVEN HOSPITAL-OWNED BATTERIES TO TRY AND RESOLVE THE ISSUE. ON FOLLOWING VISIT ON (B)(6) 2022 THE ISSUE CONTINUED AND WAS ATTRIBUTED TO BATTERY CLIP FAILURE FROM CLIPS REPLACED IN AUGUST. THE FOUR CLIPS WERE REPLACED WITH NEW ONES AND WILL BE RETURNED FOR ANALYSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444857 ↗
• MalfunctionFeb 24, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  RELATED MANUFACTURER REPORT NUMBER: 2916596-2023-01151. IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER AN ACCIDENTAL DUAL POWER LEAD DISCONNECT ON THEIR CONTROLLER.

  Patient problems: Insufficient Information

  MAUDE report 16437193 ↗