HEARTMATE®, 14V LI-ION BATTERY CLIP SET 2865Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00813024010715), received between Mar 9, 2020 and Dec 21, 2025 — classified as 4 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (23 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE 14 V BATTERIES AND BATTERY CLIPS WERE SUBMERGED WHILE THE PATIENT WAS SHOWERING IN THE HOSPITAL. THERE WERE NO ALARMS AND NO PATIENT CONSEQUENCES. IT WAS COMMUNICATED ON 05SEP2024 THAT A SHOWER BAG WAS IN USE AND WAS USED APPROPRIATELY. THE SYSTEM CONTROLLER REMAINED IN USE AS IT DID NOT GET WET. NO LOG FILES WERE PROVIDED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860314 ↗
• InjuryDec 16, 2025Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH MEDWATCH UFR (B)(4), THAT THE PATIENT ARRIVED TO CLINIC ON (B)(6) 2024. FOLLOWING EXAMINATION OF THEIR EQUIPMENT, THEY NOTED THAT THE BATTERY CLIPS DID NOT APPEAR TO HAVE MADE SMOOTH CONTACT WITH THE SYSTEM CONTROLLER. THE BATTERY CLIPS WERE REPLACED. THE HEALTHCARE PROVIDER INDICATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

  Patient problems: Insufficient Information

  MAUDE report 23822230 ↗
• InjuryNov 17, 2025Mechanical Problem; Electrical Power Problem; Material Twisted/Bent; Mechanical Problem; Electrical Power Problem; Material Twisted/Bent

  IT WAS REPORTED THROUGH MEDWATCH THAT THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2024 FOR A BATTERY AND BATTERY CLIP EVALUATION DUE TO CONCERN FOR LOW VOLTAGE ADVISORIES. IT WAS NOTED UPON EVALUATION THAT ONE CLIP HAD A BENT CONTACT AND DEBRIS. THE CLIPS WERE REPLACED. IT WAS NOTED ON THE MEDWATCH FORM THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT THAT REQUIRED INTERVENTION, BUT THE TYPE OF ADVERSE EVENT WAS NOT SPECIFIED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574457 ↗
• MalfunctionJul 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S BATTERIES AND BATTERY CLIPS HAD GOTTEN WET, BUT ALL SEEMED TO BE WORKING APPROPRIATELY. NO ISSUES NOTED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495397 ↗
• MalfunctionJun 12, 2025Disconnection; Mechanical Problem; Electrical Power Problem; Complete Loss of Power; Disconnection; Mechanical Problem; Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE PATIENT WAS WALKING BY THE WATER WITH THEIR FEET IN THE WATER, THE PATIENT STUMBLED AND FELL INTO THE WATER. THE SYSTEM CONTROLLER AND BATTERY CLIPS WERE WET AS A RESULT AND THE SYSTEM CONTROLLER GAVE AN ALARM AFTER THIS EVENT. THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED, AND THE DEVICE WOULD NOT RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199068 ↗
• MalfunctionJun 2, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE BATTERY CLIPS HAD A BROKEN O RING. THE CLIPS WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128975 ↗
• MalfunctionMay 13, 2025Mechanical Problem; Electrical Power Problem; Mechanical Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENTS BATTERIES WERE GETTING WET UPON SHOWERING. THE SYSTEM CONTROLLER WAS ALARMING FOR LOW VOLTAGE. WHEN THE PATIENT LOOKED IN THEIR SHOWER BAG, THE PATIENT NOTICED THE BATTERIES WERE WET WITH WATER AT THE BOTTOM OF THE SHOWER BAG. THE SYSTEM CONTROLLER WAS IN THE SYSTEM CONTROLLER HOLDER AND WAS NOT WET. THE PATIENT CONNECTED TO MOBILE POWER UNIT (MPU) POWER AND WAS INSTRUCTED TO USE NEW BATTERY CLIPS AND BATTERIES. THE OLD BATTERIES AND BATTERY CLIPS WERE TAKEN OUT OF USE. NO WATER DAMAGE TO THE SYSTEM CONTROLLER WAS OBSERVED AND THE SYSTEM CONTROLLER PASSED A SELF-TEST. LOG FILE REVIEW DID NOT REVEAL ANY LOW VOLTAGE EVENTS; HOWEVER, THESE EVENTS MAY HAVE BEEN OVERWRITTEN BY NEW INCOMING DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010940 ↗
• MalfunctionApr 1, 2025Disconnection; Overheating of Device; Electrical Power Problem; Disconnection; Overheating of Device; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SECOND LOW VOLTAGE ALARM IN THE LAST MONTH AND THE BATTERY CLIPS HAD BEEN PREVIOUSLY REPLACED. THE PATIENT ALSO REPORTED SMELLING SMOKE AND BURNING PLASTIC COMING FROM THEIR BATTERY CLIPS ON THE MORNING OF (B)(6) 2025. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED A FEW UNUSUAL POWER CABLE DISCONNECTS WHILE UTILIZING BATTERY POWER. THESE ALARMS APPEARED TO BE THE RESULT OF RELATIVE STATE OF CHARGE (RSOC) (BATTERY DATA) INVALID FLAGS. THESE TYPES OF ALARMS ARE TYPICALLY CAUSED BY A POOR CONNECTION BETWEEN THE BATTERIES AND THE CLIPS. THE VOLTAGE READINGS IN THE LOG APPEARED WITHIN NORMAL PARAMETERS AND THE LOG DID NOT CONTAIN ANY LOW VOLTAGE ALARMS. THE CAUSE OF THE ALARMS SEEMED TO BE DUE TO POOR CONNECTIONS BETWEEN THE BATTERIES AND THE BATTERY CLIPS. THE BATTERY CLIPS WERE EXCHANGED AND THERE WAS NO ADVERSE PATIENT IMPACT. THE ALARMS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741303 ↗
• MalfunctionApr 1, 2025Disconnection; Overheating of Device; Electrical Power Problem; Disconnection; Overheating of Device; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SECOND LOW VOLTAGE ALARM IN THE LAST MONTH AND THE BATTERY CLIPS HAD BEEN PREVIOUSLY REPLACED. THE PATIENT ALSO REPORTED SMELLING SMOKE AND BURNING PLASTIC COMING FROM THEIR BATTERY CLIPS ON THE MORNING OF (B)(6)2025. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED A FEW UNUSUAL POWERS CABLE DISCONNECTS WHILE UTILIZING BATTERY POWER. THESE ALARMS APPEARED TO BE THE RESULT OF RELATIVE STATE OF CHARGE (RSOC) (BATTERY DATA) INVALID FLAGS. THESE TYPES OF ALARMS ARE TYPICALLY CAUSED BY A POOR CONNECTION BETWEEN THE BATTERIES AND THE CLIPS. THE VOLTAGE READINGS IN THE LOG APPEARED WITHIN NORMAL PARAMETERS AND THE LOG DID NOT CONTAIN ANY LOW VOLTAGE ALARMS. THE CAUSE OF THE ALARMS SEEMED TO BE DUE TO POOR CONNECTIONS BETWEEN THE BATTERIES AND THE BATTERY CLIPS. THE BATTERY CLIPS WERE EXCHANGED AND THERE WAS NO ADVERSE PATIENT IMPACT. THE ALARMS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741257 ↗
• MalfunctionApr 1, 2025Disconnection; Overheating of Device; Electrical Power Problem; Disconnection; Overheating of Device; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SECOND LOW VOLTAGE ALARM IN THE LAST MONTH AND THE BATTERY CLIPS HAD BEEN PREVIOUSLY REPLACED. THE PATIENT ALSO REPORTED SMELLING SMOKE AND BURNING PLASTIC COMING FROM THEIR BATTERY CLIPS ON THE MORNING OF (B)(6) 2025. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED A FEW UNUSUAL POWERS CABLE DISCONNECTS WHILE UTILIZING BATTERY POWER. THESE ALARMS APPEARED TO BE THE RESULT OF RELATIVE STATE OF CHARGE (RSOC) (BATTERY DATA) INVALID FLAGS. THESE TYPES OF ALARMS ARE TYPICALLY CAUSED BY A POOR CONNECTION BETWEEN THE BATTERIES AND THE CLIPS. THE VOLTAGE READINGS IN THE LOG APPEARED WITHIN NORMAL PARAMETERS AND THE LOG DID NOT CONTAIN ANY LOW VOLTAGE ALARMS. THE CAUSE OF THE ALARMS SEEMED TO BE DUE TO POOR CONNECTIONS BETWEEN THE BATTERIES AND THE BATTERY CLIPS. THE BATTERY CLIPS WERE EXCHANGED AND THERE WAS NO ADVERSE PATIENT IMPACT. THE ALARMS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741186 ↗
• MalfunctionApr 1, 2025Disconnection; Overheating of Device; Electrical Power Problem; Disconnection; Overheating of Device; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SECOND LOW VOLTAGE ALARM IN THE LAST MONTH AND THE BATTERY CLIPS HAD BEEN PREVIOUSLY REPLACED. THE PATIENT ALSO REPORTED SMELLING SMOKE AND BURNING PLASTIC COMING FROM THEIR BATTERY CLIPS ON THE MORNING OF (B)(6) 2025. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED A FEW UNUSUAL POWERS CABLE DISCONNECTS WHILE UTILIZING BATTERY POWER. THESE ALARMS APPEARED TO BE THE RESULT OF RELATIVE STATE OF CHARGE (RSOC) (BATTERY DATA) INVALID FLAGS. THESE TYPES OF ALARMS ARE TYPICALLY CAUSED BY A POOR CONNECTION BETWEEN THE BATTERIES AND THE CLIPS. THE VOLTAGE READINGS IN THE LOG APPEARED WITHIN NORMAL PARAMETERS AND THE LOG DID NOT CONTAIN ANY LOW VOLTAGE ALARMS. THE CAUSE OF THE ALARMS SEEMED TO BE DUE TO POOR CONNECTIONS BETWEEN THE BATTERIES AND THE BATTERY CLIPS. THE BATTERY CLIPS WERE EXCHANGED AND THERE WAS NO ADVERSE PATIENT IMPACT. THE ALARMS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740260 ↗
• InjuryMar 13, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE CLINIC ON (B)(6) 2024 WITH A COMPLAINT OF POWER CABLE DISCONNECT ALARMS OCCURRING WHILE ON BATTERY POWER WITH ONE BATTERY CLIP. THE INTERMITTENT CONNECTION ISSUES ONLY OCCURRED ON THE ONE BATTERY CLIP. THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR INVESTIGATED THE BATTERY CLIP AND FOUND A MISCOMMUNICATION, THE BATTERY CLIP WAS EXCHANGED. THE EVENT REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE.

  Patient problems: Insufficient Information

  MAUDE report 21595170 ↗
• MalfunctionDec 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOWER BAG FILLED WITH WATER WHILE THEY WERE SHOWERING, DESPITE THE CUSTOMER REPORTING THAT THE SHOWER BAG HAD BEEN USED CORRECTLY BY THE PATIENT. THE SYSTEM CONTROLLER WAS WET BUT RECEIVED THE LEAST AMOUNT OF WATER DUE TO BEING AT THE TOP OF THE SHOWER BAG. THE BATTERIES AND BATTERY CLIPS AT THE BOTTOM OF THE SHOWER BAG WERE SUBMERGED IN WATER. MULTIPLE AUDIBLE ALARMS WERE HEARD BY THE PATIENT, WHICH RESOLVED AFTER THEY DRIED THE EQUIPMENT, BUT NO ALARMS WERE FOUND DURING THEIR CLINIC VISIT, AND NO FURTHER ALARMS WERE HEARD. THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE ENTIRE EVENT, AND NO CHANGES WERE MADE TO THE CONTROLLER. THERE WAS NO DAMAGE TO ANY OF THE EQUIPMENT. EVENT LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED ROUTINE EVENTS DESPITE THE WATER EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918826 ↗
• MalfunctionNov 14, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT HAD A LOW VOLTAGE ADVISORY ALARM THAT WAS NOT RESOLVED EVEN AFTER THE BATTERY AND BATTERY CLIP WERE REPLACED. THE PATIENT WENT TO THE HOSPITAL OUTPATIENT AND THE BATTERY AND BATTERY CLIP HAD RUSTED AND CORRODED TERMINALS. THE CAUSE OF THE CORROSION ON THE TERMINALS WAS UNKNOWN. THE ALARMS STOPPED WHEN THE MOBILE POWER UNIT (MPU) WAS USED. THE SYSTEM CONTROLLER, TWO BATTERIES, AND FOUR BATTERY CLIPS WERE REPLACED WITH NEW ONES. THE EVENT LOG FILES CAPTURED SEVERAL ODD LOW POWER ADVISORIES WHEN THE PATIENT WAS CONNECTED TO THE BATTERIES. THERE WERE NO OTHER UNUSUAL EVENTS CAPTURED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685689 ↗
• MalfunctionNov 14, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT HAD A LOW VOLTAGE ADVISORY ALARM THAT WAS NOT RESOLVED EVEN AFTER THE BATTERY AND BATTERY CLIP WERE REPLACED. THE PATIENT WENT TO THE HOSPITAL OUTPATIENT AND THE BATTERY AND BATTERY CLIP HAD RUSTED AND CORRODED TERMINALS. THE CAUSE OF THE CORROSION ON THE TERMINALS WAS UNKNOWN. THE ALARMS STOPPED WHEN THE MOBILE POWER UNIT (MPU) WAS USED. THE SYSTEM CONTROLLER, TWO BATTERIES, AND FOUR BATTERY CLIPS WERE REPLACED WITH NEW ONES. THE EVENT LOG FILES CAPTURED SEVERAL ODD LOW POWER ADVISORIES WHEN THE PATIENT WAS CONNECTED TO THE BATTERIES. THERE WERE NO OTHER UNUSUAL EVENTS CAPTURED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685614 ↗
• MalfunctionNov 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HAVING INTERMITTENT ALARMS, AND THE BATTERY CLIPS WERE EXCHANGED SINCE THEY WERE NOT RECOGNIZING FULLY CHARGED BATTERIES ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604093 ↗
• MalfunctionNov 4, 2024Corroded; Disconnection; Corroded; Disconnection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT YELLOW ADVISORIES TELLING THE PATIENT TO CONNECT POWER. IT WAS NOTED THAT THIS ALARM WAS ON THE WHITE POWER CABLE SIDE. THE HEALTH PROFESSIONAL SWITCHED THE BATTERY CLIP CONNECTED TO THE BLACK POWER CABLE, WITH THE BATTERY CLIP CONNECTED TO THE WHITE POWER CABLE AND THE ALARM REMAINED. LATER, THE HEALTH PROFESSIONAL TRIED TRANSITIONING TO NEW BATTERIES AND CLIPS, AND THE ALARM STILL REMAINED. LOG FILES WERE SUBMITTED FOR REVIEW. THE EVENT LOG FILES CAPTURED POWER CABLE DISCONNECTS, WHICH INDICATED A WEAK CONNECTION BETWEEN THE BATTERIES AND CLIPS. THE BATTERY CLIPS WERE EXCHANGED, AND NEW BATTERIES WERE ORDERED. THERE WAS CORROSION PRESENT ON THE CONTACTS OF BOTH THE BATTERIES AND BATTERY CLIPS DESPITE BEING CLEANED. THE ALARMS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20602429 ↗
• MalfunctionOct 14, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN URGENT LOG FILE READING WAS REQUESTED FOR A PATIENT WHOSE CONSOLIDATED BAG WITH THE BATTERIES THEY WERE CONNECTED TO FELL IN WATER FOR A FEW SECONDS. THERE WAS A POWER CABLE DISCONNECT ON THE WHITE POWER CABLE FOR 30 SECONDS THAT RESOLVED WHEN THE BATTERY AND CLIP WERE PULLED OUT OF WATER. A FEW CONTROLLER SELF-TESTS WERE DONE, AND NO ISSUES WERE NOTED. THE OVERALL HISTORY OF THE LOG FILE WAS JUST OVER 3 HOURS DUE TO FREQUENT PULSATILITY INDEX (PI) EVENTS FILLING UP THE DATA BANK OF THE LOG FILE. THE DATA ON (B)(6)2024 WAS UNAVAILABLE. HOWEVER, IT WAS RECOMMENDED TO EXCHANGE THE EQUIPMENT THAT WAS SUBMERGED DUE TO THE POTENTIAL FOR CORROSION OVER TIME FROM THE MOISTURE INGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441416 ↗
• MalfunctionAug 13, 2024Mechanical Problem; Mechanical Problem

  IT WAS COMMUNICATED ON (B)(6) 2024 THAT A SHOWER BAG WAS IN USE AND WAS USED APPROPRIATELY. THE SYSTEM CONTROLLER REMAINED IN USE AS IT DID NOT GET WET. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975550 ↗
• MalfunctionJul 17, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT HAD A LOW VOLTAGE ADVISORY ALARM THAT WAS NOT RESOLVED EVEN AFTER THE BATTERY AND BATTERY CLIP WERE REPLACED. THE PATIENT WENT TO THE HOSPITAL OUTPATIENT AND THE BATTERY AND BATTERY CLIP HAD RUSTED AND CORRODED TERMINALS. THE ALARMS STOPPED WHEN THE MOBILE POWER UNIT (MPU) WAS USED. THE SYSTEM CONTROLLER, TWO BATTERIES, AND FOUR BATTERY CLIPS WERE REPLACED WITH NEW ONES. THE EVENT LOG FILES CAPTURED SEVERAL ODD LOW POWER ADVISORIES WHEN THE PATIENT WAS CONNECTED TO THE BATTERIES. THERE WERE NO OTHER UNUSUAL EVENTS CAPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763665 ↗
• MalfunctionJul 17, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT HAD A LOW VOLTAGE ADVISORY ALARM THAT WAS NOT RESOLVED EVEN AFTER THE BATTERY AND BATTERY CLIP WERE REPLACED. THE PATIENT WENT TO THE HOSPITAL OUTPATIENT AND THE BATTERY AND BATTERY CLIP HAD RUSTED AND CORRODED TERMINALS. THE ALARMS STOPPED WHEN THE MOBILE POWER UNIT (MPU) WAS USED. THE SYSTEM CONTROLLER, TWO BATTERIES, AND FOUR BATTERY CLIPS WERE REPLACED WITH NEW ONES. THE EVENT LOG FILES CAPTURED SEVERAL ODD LOW POWER ADVISORIES WHEN THE PATIENT WAS CONNECTED TO THE BATTERIES. THERE WERE NO OTHER UNUSUAL EVENTS CAPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763647 ↗
• MalfunctionMar 20, 2024Corroded; Disconnection; Corroded; Disconnection

  IT WAS REPORTED THAT WHILE THE PATIENT WAS ON VACATION IN JAMAICA, THEY EXPERIENCED A CONNECT POWER ALARM EVEN WHEN TWO FULLY CHARGED BATTERIES WERE CONNECTED. VIA A PHONE SUPPORT, THE PATIENT EXCHANGED THEIR SYSTEM CONTROLLER AND CLEANED THE CONTACTS, BUT THE ISSUE COULD NOT BE RESOLVED. FURTHER INVESTIGATION SHOWED THAT THERE WAS SOME CORROSION ON THE CONTACTS OF THE BATTERY CLIP. NO INFORMATION WAS AVAILABLE ABOUT THE ROOT CAUSE OF THE CORROSION. PER THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR ADVICE, THE PATIENT ORGANIZED SOME SANDPAPER AND REMOVED THE CORROSION WHICH RESOLVED THE ALARMS. ONCE THE PATIENT RETURNS FROM VACATION, THEY WERE TO PRESENT TO THE IMPLANTING CENTER FOR A BATTERY CLIP EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941554 ↗
• MalfunctionMar 19, 2024Corroded; Electrical Power Problem; Corroded; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC ON (B)(6) 2024, AND THE BATTERIES AND BATTERY CLIPS HAD CORROSION AND WERE REPLACED ALONG WITH THE UNIVERSAL BATTERY CHARGER (UBC) DUE TO THE UBC ALSO HAVING CORROSION. LOG FILES WERE SENT FOR REVIEW, NOTING SEVERAL LOW VOLTAGE ALARMS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE ALARMS RESOLVED WITH THE UBC EXCHANGE. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01459 (BATTERY); RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01328 (BATTERY); RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01458 (UNIVERSAL BATTERY CHARGER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935492 ↗
• MalfunctionMar 7, 2024Corroded; Corroded

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ALARMS RESOLVED AFTER EXCHANGING THE BATTERY CLIP AND BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862729 ↗
• InjuryFeb 28, 2024Electrical Power Problem; Electrical Power Problem

  IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS NOT SYMPTOMATIC OR INJURED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803153 ↗