HEARTMATE®, POWER MODULE PATIENT CABLE 14V 103426Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00813024010784), received between Feb 20, 2019 and Jan 28, 2026 — classified as 4 injuries, 59 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Electrical Power Problem

  IT WAS REPORTED THAT THE LOG FILES WERE SUBMITTED FOR EVALUATION. THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR HAD FEEDBACK THAT ALL ALARMS WERE NOT BEING CAPTURED AND SHOWN ON THE SYSTEM MONITOR. A LOG FILES REVIEW SHOWED DATA FROM (B)(6) 2025 AT 4:21:23 TO (B)(6) 2025 AT 11:01:13. MOST OF THE EVENTS WERE ASSOCIATED WITH A (F56) V_UNABLE_CHARGE_EBB POWER FAULT FLAGS, WHICH WAS DUE TO WORN OR DAMAGED PATIENT CABLE. IT WAS RECOMMENDED THAT THE PATIENT CABLE BE REMOVED AND DISCARDED. IT WAS PROVIDING ABOUT 12.5 VOLTS TO THE SYSTEM CONTROLLER. THIS WAS NOT ENOUGH VOLTAGE FOR THE SYSTEM CONTROLLER TO OPERATE THE CHARGING CIRCUITRY FOR THE EMERGENCY BACKUP BATTERY (EBB). MOTOR FUNCTION WAS NOT AFFECTED BY THESE EVENTS. THE POWER FAULT FLAGS WERE RECORDABLE EVENTS BUT NOT ALARMS. THE ALARM HISTORY ON THE SYSTEM MONITOR WOULD NOT SHOW THESE EVENTS. THESE EVENTS WERE OCCURRING FREQUENTLY AND WAS QUICKLY FILLING UP THE LOG FILE HISTORY. THE LATEST LOG FILES WERE PROVIDED. THE PATIENT CABLE WAS EXCHANGED. THE EVENT AND PERIODIC LOGS WERE ABLE TO BE SEEN AND TALLIED ACCORDINGLY. THE LOG FILES SHOWED THE PATIENT CABLE STILL DELIVERING LESS THAN 13.5 VOLTS. THIS NUMBER SHOULD BE 14.5 V FOR A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201341 ↗
• MalfunctionDec 8, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS LATER REPORTED ON 15JAN2026 THAT THE CAUSE OF THE HEARTMATE TOUCH CONNECTIVITY ISSUES WAS IDENTIFIED TO BE THE PATIENT CABLE BETWEEN THE SYSTEM CONTROLLER AND POWER MODULE, NOT THE HEARTMATE TOUCH WIRELESS ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23747137 ↗
• MalfunctionNov 17, 2025Failure to Interrogate; Mechanical Problem; Failure to Interrogate; Mechanical Problem

  IT WAS REPORTED THAT WHEN THE PATIENT WAS SEEN IN THE CLINIC, THERE WERE ISSUES WITH GETTING THE SYSTEM CONTROLLER TO CONNECT TO THE HEARTMATE (HM) TOUCH. THE PATIENT WAS ASKED TO COME IN AGAIN ON (B)(6) 2025 TO TROUBLESHOOT. THERE WERE NO PROBLEMS CONNECTING HIS CONTROLLER OR HIS BACKUP CONTROLLER TO THE HM TOUCH AND ALL THE PINS AT THE CONNECTION SITE APPEARED TO LOOK GOOD. IT SEEMED THAT ONE OF THE PINS IN THE INTERROGATOR WAS A BIT WONKY AND IT WAS PROBABLY THE PROBLEM, NOT THE PATIENT'S EQUIPMENT. THE CLINIC DETERMINED THAT THERE WAS A PIN THAT LOOKED A LITTLE BENT IN THE WHITE PORT OF THE POWER MODULE PATIENT CABLE. LOG FILE REVIEW WAS REQUESTED WHICH REVEALED ONLY ROUTINE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569056 ↗
• MalfunctionOct 7, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT UPON TRANSFER OUT OF THE OPERATING ROOM (OR), THE PATIENT WAS PLACED ON BATTERIES WITHOUT ISSUE. UPON ARRIVAL TO THE INTENSIVE CARE UNIT (ICU), BLUETOOTH CONNECTION WAS ESTABLISHED ON THE HEARTMATE TOUCH (HMT) AND THE CONNECTION TO THE SYSTEM CONTROLLER WAS NOT RECOGNIZED. THE POWER MODULE PATIENT CABLE WAS REPLACED. UPON INSPECTION OF THE ORIGINAL POWER MODULE CABLE, A BENT PIN WAS FOUND ON THE WHITE CONNECTION. NO HARM WAS CAUSED TO THE PATIENT AND THERE WAS NO DELAY IN CARE. THE PATIENT WAS STABLE AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23238718 ↗
• MalfunctionJun 19, 2025Disconnection; Overheating of Device; Electrical Power Problem; Disconnection; Overheating of Device; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT BEING CONNECTED TO THE POWER MODULE (PM) FROM BATTERY POWER. THE PATIENT WAS STILL CONNECTED TO THE BATTERY ON THE BLACK CABLE AND THE WHITE CABLE HAD BEEN SWITCHED TO THE PM. A YELLOW WRENCH ALARM CAME ON THE POWER MODULE AND THE PATIENT¿S SYSTEM CONTROLLER SHOWED ¿LOW BATTERY¿. THE PM WAS CHECKED BY CLINICAL ENGINEERING AND FOUND TO HAVE NO ISSUES. THIS EVENT HAPPENED WITH TWO PATIENT CABLES, ONE OF WHICH WAS VERY HOT TO TOUCH. THE ALARMS RESOLVED AFTER SWITCHING TO A THIRD PATIENT CABLE. THE PRESUMPTION WAS THAT THIS WAS A PATIENT CABLE ISSUE. LOG FILES WERE SENT TO ENSURE THAT THERE WAS NOTHING ADDITIONAL NOTED. THE EVENT LOG CAPTURED ODD VOLTAGES ON THE WHITE POWER LEAD WHEN CONNECTED TO THE WALL UNIT ALL THROUGHOUT THE LOG FILE. IT SHOULD'VE BEEN 14 VOLTS AND WAS CONSISTENTLY 9 -11 VOLTS WHICH WAS LIKELY CAUSING VOLTAGE ISSUES AND LOOKED LIKE SOME RANDOM POWER CABLE DISCONNECT EVENTS. IT APPEARED THAT THE PATIENT CABLE MAY HAVE BEEN THE CULPRIT. THE LOG FILE ALSO CAPTURED LOW VOLTAGE HAZARD/NO EXTERNAL POWER EVENT ON (B)(6) 2025 AT 1338 WHICH ENABLED THE BACKUP BATTERY (EBB) IN THE SYSTEM CONTROLLER UNTIL THE PATIENT WAS CHANGED TO BATTERY POW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293358 ↗
• MalfunctionJun 5, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF AN OVERHEATED CONTROLLER WHILE CONNECTED TO THE POWER MODULE AT HOME. THE CONTROLLER AND PATIENT CABLE WERE EXCHANGED AND COLLECTED FOR ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149978 ↗
• InjuryMay 23, 2025Unintended Electrical Shock; Unintended Electrical Shock

  ADDITIONAL INFORMATION RECEIVED ON 27MAY2025 STATED THAT THE PATIENT RECEIVED NO SHOCKS SINCE BEING ON THE UNGROUNDED CABLE. THE SYSTEM CONTROLLER AND DRIVELINE THAT THE PATIENT WAS CURRENTLY ON APPEARED TO BE IN GOOD CONDITION. THE ELECTRICAL TAPE THAT WAS COVERING THE SCREWS WAS REMOVED. NEW LOG FILES WERE SENT FOR REVIEW. THE LOG FILE CAPTURED 126 PULSATILITY INDEX (PI) EVENTS ON (B)(6) 2025. THESE EVENTS WERE CONSIDERED ROUTINE. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MCS EQUIPMENT APPEARED TO HAVE OPERATED AS INTENDED.

  Patient problems: Electric Shock

  MAUDE report 22079313 ↗
• InjuryMay 23, 2025Unintended Electrical Shock; Unintended Electrical Shock

  ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025 STATED THAT THE PATIENT WENT INTO THE CLINIC AND WAS EVALUATED WHILE CONNECTED TO A GROUNDED PATIENT CABLE. THE PATIENT SAID THAT THEY STILL FELT LIGHT SHOCKS WITH THEIR FOREARMS WHEN THEY TOUCHED THE TWO LITTLE METAL SCREWS ON THEIR CONTROLLER. IT WAS RECOMMENDED FOR THE UNGROUNDED CABLE TO BE CONTINUED TO BE USED AT HOME. MORE LOG FILES WERE SENT FOR REVIEW. THERE WERE NO UNUSUAL EVENTS RECORDED IN THE EVENT LOG FILE HISTORY. THE RECORDED DATA INDICATED THAT THE MCS EQUIPMENT HAD OPERATED AS INTENDED.

  Patient problems: Electric Shock

  MAUDE report 22079183 ↗
• InjuryMay 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT'S POWER MODULE POWER CABLE CORDS WERE FRAYED, AND WIRES WERE EXPOSED. WHILE DOING POWER CHANGES, THE PATIENT WAS SHOCKED. THE POWER CABLE CORDS WERE REPLACED. LOG FILES WERE OBTAINED AND UPON INTERROGATION THERE WERE NOT ANY NOTED ALARMS OR PARAMETERS THAT WERE NOT WITHIN NORMAL LIMITS. THE PATIENT WAS NOT INITIALLY SYMPTOMATIC, HOWEVER AFTER LOG FILES WERE OBTAINED AND THE PATIENT HAD BEEN WALKING, THE PATIENT BEGAN TO COMPLAIN ABOUT FEELING LIGHTHEADED. THE PATIENT LIED DOWN. THERE WERE NO ACTIVE ALARMS DURING THE SHOCK AND THE PATIENT DID NOT HAVE AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). LOG FILES WERE SUBMITTED FOR REVIEW AND DID NOT CAPTURE ANY UNUSUAL EVENTS. THE PATIENT DID NOT RECEIVE ANY MORE SHOCKS ONCE THE POWER CORDS WERE REPLACED.

  Patient problems: Electric Shock; Presyncope

  MAUDE report 21944041 ↗
• MalfunctionNov 15, 2024Use of Device Problem; Electrical Power Problem; Use of Device Problem; Electrical Power Problem

  ADDITIONAL INFORMATION PROVIDED THAT THE PATIENT CABLE HAD BEEN REPLACED. THE PATIENT CONTINUED TO HAVE LOW VOLTAGE ALARMS WHILE ON BATTERY POWER, BUT THE PATIENT'S BATTERIES SHOWED 2-3 BARS REMAINING. LOG FILES WERE SENT FOR REVIEW, AND THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE HISTORY. THE LOW POWER ALARMS ALL APPEARED TO BE RELATED TO NORMAL BATTERY DEPLETION. THE MECHANICAL CIRCULATORY SUPPORT EQUIPMENT WAS OPERATING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698492 ↗
• MalfunctionOct 24, 2024Failure to Interrogate; Mechanical Problem; Failure to Interrogate; Mechanical Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING TROUBLE MAKING BLUETOOTH CONNECTION TO THEIR HEARTMATE TOUCH (HMT) UNITS WHILE IN THEIR SUPPLY ROOM WITH THE DOOR CLOSED. THE HMTS WOULD ONLY INTERMITTENTLY CONNECT WHEN THE EQUIPMENT DOOR WAS SHUT BUT WOULD CONNECT ONCE OPEN. THE SCREEN WOULD SHOW A WHITE WHEEL SPINNING WHILE BLUETOOTH ADAPTORS ATTEMPTED CONNECTION BUT WOULD NOT COMPLETE CONNECTION. IT WAS LATER REPORTED THAT BLUETOOTH CONNECTION SEEMED TO BE SUCCESSFUL, HOWEVER THERE WERE ISSUES WITH BOTH DEVICES DROPPING MID CONNECTION WITHOUT A RHYME OR REASON. IT WAS REPORTED THAT THE FINAL RESOLUTION WAS THE DATA CORD FROM THE HMT TO THE VENTRICULAR ASSIST DEVICE (VAD) WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527822 ↗
• MalfunctionOct 10, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE POWER MODULE REPEATEDLY ALARMED. THE POWER MODULE WAS SENT IN FOR REPAIR. THE POWER MODULE PATIENT CABLE WAS RETURNED AND DID NOT PASS TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423790 ↗
• MalfunctionAug 23, 2024Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT HAD A NO EXTERNAL POWER WHILE CONNECTED TO POWER MODULE AND PATIENT CABLE. THE PATIENT WAS SWITCHED TO BATTERY POWER TO RESOLVE ALARMS. THE POWER MODULE AND PATIENT CABLE WERE REPLACED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20054389 ↗
• MalfunctionMar 8, 2024Electrical Power Problem; No Apparent Adverse Event; Electrical Power Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT EVENT LOG FILES WERE SUBMITTED FOR REVIEW. THE PATIENT HAD MULTIPLE LOW VOLTAGE ALARMS WHILE PLUGGED INTO THE WALL OUTLET. THE EVENT LOG FILES CAPTURED SEVERAL ODD LOW POWER ALARMS WHILE TETHERED TO THE BATTERIES. IT WAS NOTED THAT THE VOLTAGE VALUES WHEN CONNECTED TO THE MOBILE POWER UNIT (MPU) APPEARED TO BE LOWER THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870778 ↗
• MalfunctionFeb 16, 2024Electrical Power Problem; Complete Loss of Power; Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT LOG FILE REVIEW WAS REQUESTED FOR A PATIENT WHO WAS NOTED TO HAVE A NO EXTERNAL POWER (NEP) ALARM. THE EVENT LOG FILE CAPTURED NEP EVENTS 26JAN2024 AT 1849-1850 WHILE USING WALL POWER. IT APPEARED THAT BOTH POWER CABLE LEADS WERE DISCONNECTED AT THE SAME TIME ENABLING THE BACKUP BATTERY IN THE SYSTEM CONTROLLER UNTIL POWER WAS RESTORED TO THE MOBILE POWER UNIT / POWER MODULE. THE EVENT LASTED ABOUT 1 MINUTE WITH NO INTERRUPTION IN PUMP SUPPORT. TECHNICAL SERVICES NOTED THAT IF THE PATIENT WAS USING A POWER MODULE AT HOME, THE PATIENT CABLE NEEDED TO BE REPLACED AS IT WAS SHOWING BELOW THE 14V SPECIFICATIONS ON OCCASION. NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG FILE. IT WAS ADDITIONALLY COMMUNICATED THAT THE PATIENT WAS IN THE EMERGENCY ROOM AT THE TIME OF THE EVENT. THE SITE NOTED THAT IF THE PATIENT WAS HOOKED UP TO THE MPU, IT WAS LIKELY THE PATIENT'S HOME MPU AND IF THEY WERE ON THE POWER MODULE, IT WAS ONE FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722039 ↗
• MalfunctionJan 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  NO FUNCTIONAL ISSUE WAS REPORTED WITH THE 14V POWER MODULE PATIENT CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570820 ↗
• MalfunctionSep 26, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT CABLE WAS BROKEN AND WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816406 ↗
• MalfunctionAug 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BENT PIN ON THE POWER MODULE PATIENT CABLE AND WHITE POWER LEAD CONNECTION. A CONTROLLER EXCHANGE RELIEVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502192 ↗
• MalfunctionJul 25, 2023Electrical Power Problem; Electrical Power Problem

  AFTER FURTHER REVIEW OF THE SUBMITTED LOG FILE, THE VOLTAGE DROPS, AND LOW POWER ALARMS APPEARED TO BE DUE TO LOW SUPPLY VOLTAGE FROM THE POWER MODULE PATIENT CABLE, AND NOT THE MOBILE POWER UNIT (MPU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391848 ↗
• MalfunctionJul 17, 2023Disconnection; Electrical Power Problem; Complete Loss of Power; Disconnection; Electrical Power Problem; Complete Loss of Power

  FURTHER REVIEW OF THE SUBMITTED LVAD LOG FILES REVEALED THAT THE ABNORMAL POWER CABLE DISCONNECT/LOW POWER HAZARD/NO EXTERNAL POWER EVENTS WERE RELATED TO THE OPERATION OF THE POWER MODULE PATIENT CABLE, AND NOT THE MOBILE POWER UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334873 ↗
• MalfunctionJun 26, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT MULTIPLE POWER CABLE DISCONNECT EVENTS WERE RECORDED WHILE CONNECTING TO A POWER MODULE AT HOME. THE POWER MODULE PATIENT CABLE WAS REPLACED. LOG FILE CONFIRMED ATYPICAL POWER CABLE DISCONNECT EVENTS WHILE CONNECTED TO THE POWER MODULE. NO FURTHER ALARMS WERE NOTED AFTER THE POWER MODULE PATIENT CABLE WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17202252 ↗
• MalfunctionJun 16, 2023Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONSTANT BACKUP BATTERY (EBB) CIRCUIT FAULTS. THE BACKUP BATTERY WAS EXCHANGED, BUT THIS DID NOT RESOLVE THE ISSUE. THE CONTROLLER WAS EXCHANGED ON 22MAR2023. AFTER THE EXCHANGE, THE POWER MODULE DISPLAYED "BACKUP BATTERY DUE IN 32 MONTHS" AND "REPLACE BACKUP BATTERY". THE PATIENT ALSO EXPERIENCED A NO EXTERNAL POWER ALARM WHILE CONNECTED TO THE POWER MODULE. THE POWER MODULE, SYSTEM MONITOR AND POWER MODULE PATIENT CABLE WERE SWAPPED SEVERAL TIMES. LOG FILE ANALYSIS CAPTURED CONTINUOUS UNABLE TO CHARGE EBB POWER FAULT FLAGS WHICH OCCUR WHEN THE SUPPLY VOLTAGE TO THE CONTROLLER IS LOW. THE RECORDED VOLTAGES WERE CONSISTENTLY BELOW 12V. AS THE CONTROLLER WAS NEW, THIS INDICATED THE ISSUE WAS CAUSED BY THE POWER MODULE OR POWER MODULE PATIENT CABLE. THE ENTIRE CART THAT THE PATIENT WAS CONNECTED TO WAS REPLACED; THE NEW RECORDED VOLTAGES WERE ALL AROUND 14.6V. IT COULD NOT BE DETERMINED IF THE POWER MODULE OR THE POWER MODULE PATIENT CABLE WAS THE CAUSE OF THE VOLTAGE ISSUES. RELATED CONTROLLER MFR #: 2916596-2023-01832 RELATED POWER MODULE MFR #: 2916596-2023-03952.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144448 ↗
• MalfunctionMay 16, 2023Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EMERGENCY BACKUP BATTERY (EBB) FAULT AND SYSTEM CONTROLLER FAULT. THE CONTROLLER WAS ALSO REPORTED TO BE WARM TO THE TOUCH. A CONTROLLER FAULT ALARM ASSOCIATED WITH AN LCD FAULT OCCURRED ON (B)(6) 2023 AT 1:08 AND ON (B)(6) 2023 AT 16:55. THE EVENTS WERE VERY BRIEF AND SELF-CORRECTED. AN EBB FAULT ALARM OCCURRED ON (B)(6) 2023 AT 21:29 AND AGAIN ON (B)(6) 2023 AT 10:30. THE RECORDED DATA INDICATED THAT THE PATIENT CABLE CONNECTED TO THE SYSTEM CONTROLLER AT THE TIME OF THE EVENTS WAS SUPPLYING LOW VOLTAGES TO THE SYSTEM CONTROLLER. THE LOW VOLTAGES FROM THE OLD PATIENT CABLE MAY HAVE BEEN THE CAUSE OF THE EBB FAULT ALARM AS WELL AS THE WARMING OF THE SYSTEM CONTROLLER. THE PATIENT CABLE WAS EXCHANGED WHICH RESOLVED THE ALARMS AND THE WARM TEMPERATURE OF THE SYSTEM CONTROLLER. RELATED MFR # 2916596-2023-02587.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942461 ↗
• MalfunctionApr 19, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT A PIN FROM THE POWER MODULE PATIENT CABLE WAS FOUND IN THE PATIENT'S WHITE POWER CABLE OF THE CONTROLLER. THE POWER MODULE WAS STILL ABLE TO PROVIDE POWER TO THE SYSTEM CONTROLLER, HOWEVER COMMUNICATION WITH THE HEARTMATE TOUCH WAS INTERRUPTED. THE SYSTEM CONTROLLER AND POWER MODULE PATIENT CABLE WERE EXCHANGED WHICH RESOLVED THE ISSUE. THERE WAS NO IMPACT TO THE PATIENT. RELATED MFR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770891 ↗
• MalfunctionApr 19, 2023Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED, THAT THE PATIENT RETURNED THEIR SYSTEM CONTROLLER FOR FUNCTIONAL TESTING AT THE HOSPITAL. THE SYSTEM CONTROLLER WAS KEPT BY THE HOSPITAL AS A BACKUP SYSTEM CONTROLLER. THE FUNCTIONAL TEST OF THE SYSTEM CONTROLLER WAS DONE, DUE TO SAFETY ISSUES BECAUSE THE POWER CABLE DISCONNECT ALARM WAS TRIGGERED. THE ALARM WAS CONTRIBUTED TO THE SHORT CIRCUITED 14V PATIENT CABLE. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-01875 (SYSTEM CONTROLLER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770121 ↗