HEARTMATE MOBILE POWER UNIT, CA 107754OUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00813024013006), received between Jul 17, 2018 and Mar 18, 2024 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Disconnection; Electrical Power Problem; Disconnection; Electrical Power Problem

  IT WAS REPORTED THAT EVENT LOG FILES WERE SUBMITTED FOR REVIEW. DEVICE INTERROGATION CAPTURED A LOW VOLTAGE EVENT ON (B)(6) 2024 WHICH THE PATIENT ATTRIBUTED TO ACCIDENTAL UNCHARGED BATTERY USAGE. THE EVENT LOG FILES CAPTURED A SERIES OF LOW POWER HAZARD EVENTS AND POWER CABLE DISCONNECTS ON (B)(6) 2024 AT 13:00 WHILE TETHERED TO THE MOBILE POWER UNIT. THESE EVENTS WERE CAUSED BY A BRIEF POWER INTERRUPTION TO THE MPU. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01649 (PUMP MLP-005050).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924817 ↗
• MalfunctionFeb 20, 2024Complete Loss of Power; Complete Loss of Power

  ADDITIONAL EVENT LOG FILE REVIEW CAPTURED A NO EXTERNAL POWER EVENT ON (B)(6) 2023 WHILE THE PATIENT WAS CONNECTED TO THE MPU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741546 ↗
• MalfunctionFeb 18, 2024Complete Loss of Power; Complete Loss of Power

  FURTHER ANALYSIS OF THE EVENT LOG FILES CAPTURED A LOSS OF POWER TO THE MOBILE POWER UNIT ON (B)(6) 2023 AT 08:18:13 AND AT 08:21:26, AND ON (B)(6) 2023 FROM 16:04:16 TO 16:04:17.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728538 ↗
• MalfunctionJan 29, 2024Complete Loss of Power; Complete Loss of Power

  THE LOG FILES CAPTURED POWER CABLE DISCONNECT/LOW POWER HAZARD/NO EXTERNAL POWER ALARM ON 31DEC2023 AT 11:49. THESE ALARMS WERE CAUSED BY THE POWER TO THE MOBILE POWER UNIT (MPU) BEING BRIEFLY INTERRUPTED. THERE WAS NO PUMP INTERRUPTION DURING THESE EVENTS, AS THE SYSTEM CONTROLLER'S BACKUP BATTERY FUNCTIONED AS INTENDED DURING THESE EVENTS. THE ALARMS RESOLVED UPON RECONNECTION OF THE MPU'S POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597761 ↗
• MalfunctionJan 19, 2024Electrical Power Problem; Complete Loss of Power; Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT EVENT LOG FILES WERE SUBMITTED FOR REVIEW. THE EVENT LOG FILES CAPTURED A COUPLE LOW VOLTAGE HAZARD EVENTS ON (B)(6) 2024 AND (B)(6) 2024. IT APPEARED THAT THE MOBILE POWER UNIT (MPU) LOST POWER WHICH TRIGGERED THE SYSTEM CONTROLLER'S BACKUP BATTERY (EBB). IT WAS UNCLEAR WHAT CAUSED THE LOSS OF POWER. THE PATIENT NOTED IT WAS BROKEN. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-00436. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547368 ↗
• MalfunctionOct 5, 2022Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUDDEN RED BATTERY ALARM WITH FULLY CHARGED BATTERIES. A SERIES OF NO EXTERNAL POWER EVENTS OCCURRED WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) CAUSED BY POWER FROM THE MPU BEING BRIEFLY INTERRUPTED. THERE WAS NO INTERRUPTION IN PUMP SUPPORT DURING THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545682 ↗
• MalfunctionMay 18, 2022Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SYSTEM CONTROLLER EXCHANGE DUE TO DAMAGE TO BEND RELIEF. FURTHER REVIEW OF THE LOG FILE REVEALED NO EXTERNAL POWER ALARM THAT ACTIVATED ON (B)(6) 2022 AT 00:07 DUE TO AC POWER DISCONNECT WHILE THE DEVICE WAS CONNECTED TO A MOBILE POWER UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428425 ↗
• MalfunctionAug 5, 2021Electrical Power Problem; Electrical Power Problem

  LOG FILES WERE REVIEWED WHICH FOUND A POWER CABLE DISCONNECT AND LOW POWER HAZARD ALARMS ON THE MPU. IT WAS NOTED THAT THE MPU HAD A LOCKING CONNECTOR. THE ALARMS WERE ATTRIBUTED TO A POWER OUTAGE AT THE PATIENT'S RESIDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284443 ↗
• MalfunctionJul 15, 2021Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT LOG FILE SUBMITTED REVEALED MULTIPLE NO EXTERNAL POWER ALARMS. THE PATIENT STATED THEY HAD BEEN HAVING POWER OUTAGES AT HOME IN THEIR APARTMENT BUILDING. THE LOG FILE CAPTURED MULTIPLE NO EXTERNAL POWER EVENTS ON (B)(6) 2021 , (B)(6) 2021 , AND (B)(6) 2021. THE EVENTS ON (B)(6) 2021 AND (B)(6) 2021 WERE CAUSED BY POWER TO THE MOBILE POWER UNIT (MPU) BEING BRIEFLY INTERRUPTED DUE TO THE AC POWER CORD COMING LOOSE AT THE MPU OR AC WALL OUTLET, OR A HOUSE POWER DISRUPTION. THE EVENT ON (B)(6) 2021 2021 APPEARED TO HAVE BEEN THE RESULT OF THE PATIENT SIMULTANEOUSLY DISCONNECTING POWER FROM BOTH CONTROLLER LEADS. THERE WAS NO INTERRUPTION IN PUMP SUPPORT DURING THESE EVENTS. THE LOG FILE ALSO NOTED A FEW LOW POWER HAZARDS BETWEEN (B)(6) 2021 AND (B)(6) 2021 THAT WERE DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE EQUIPMENT WAS OPERATING AS INTENDED. DISCUSSED RESULTS WITH PATIENT AND PATIENT STATED SOMETIMES SWITCHING VERY QUICKLY AND THE FIRST BATTERY MAY NOT BE CONNECTED PROPERLY AND MAY ALREADY MOVED ON TO THE NEXT ONE. DISCUSSED PRECAUTIONS WITH PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177932 ↗
• InjuryJul 15, 2021Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT WAS REEDUCATED AND CONTINUED TO MONITOR OUTPATIENT. THE MOBILE POWER UNIT (MPU) WAS INSPECTED BY CLINICAL ENGINEERING AND NO ISSUES WERE FOUND. THE MPU DID HAVE A V-LOCK CONNECTOR ON THE AC POWER CORD. IT WAS UNKNOWN IF THE POWER CORD CAME LOOSE AT THE WALL/OUTLET OR THE BACK OF THE UNIT. THE PATIENT HAD NO MEMORY OF THESE EVENTS. PATIENT DID HAVE A PAST HISTORY OF UNPLUGGING HIS MPU TO CHANGE LOCATIONS WHILE STILL CONNECTED. THERE WERE NO ENVIRONMENTAL CIRCUMSTANCES THAT WOULD HAVE AFFECTED AC POWER AT THE TIME OF THE EVENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 12174253 ↗
• MalfunctionJun 8, 2021Electrical Power Problem; Complete Loss of Power; Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL ALARMS. A LOG FILE WAS SENT IN FOR REVIEW WHICH FOUND LOW VOLTAGE EVENTS ON (B)(6) 2021 WHILE CONNECTED THE MOBILE POWER UNIT AND APPEARS THAT THERE WAS A TOTAL LOSS OF POWER TO THE MPU ENABLING THE BACKUP BATTERY IN THE CONTROLLER TO POWER THE LVAS UNTIL THE POWER WAS RESTORED TO THE MPU. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962845 ↗
• MalfunctionApr 28, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY ROOM (ER) WITH NEAR SYNCOPE. LOG FILES WERE PROVIDED FOR ANALYSIS. A REVIEW OF THE LOG FILES NOTED SEVERAL LOW VOLTAGE/NO EXTERNAL POWER EVENTS WHILE USING THE MOBILE POWER UNIT (MPU) ON (B)(6) 2021 AT 00:36, 02:28, 02:29, AND 06:04. ALL OF THESE EVENTS WERE DUE TO A TOTAL LOSS OF POWER TO THE MPU ENABLING THE BACKUP BATTERY IN THE CONTROLLER UNTIL POWER WAS RETURNED TO THE MPU. THERE WAS NO LOSS OF PUMP SUPPORT DURING THESE EVENTS. A COUPLE OF LOW FLOW EVENTS ON (B)(6) 2021 AT 04:12 AND 04:26 WHERE THE ESTIMATED FLOW WAS AT THE 2.5 LITERS PER MINUTE (LPM) THRESHOLD BUT WAS NOT SUSTAINED LONG ENOUGH TO TRIGGER THE AUDIBLE ALARM. NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG FILE. THE PATIENT STATED THAT HE PULLED THE POWER CORD TO THE MPU OUT OF THE WALL. THE PATIENT HAS THE V LOCK ON THE MPU A/C POWER CORD. THE ACCOUNT WAS UNCERTAIN HOW THE PATIENT MANAGED TO PULL THE POWER CORD OUT OF THE WALL THREE TIMES. THE MPU WAS NOT TO BE RETURNED. THE LOWER FLOWS RESOLVED WITH FLUID BOLUS. THE PATIENT WAS DEHYDRATED DUE TO TAKING TOO MUCH DIURETIC. THE DEVICE OPERATED AS EXPECTED. THE PATIENT BECAME LIGHTHEADED WHILE RUNNING AT WORK. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739523 ↗
• MalfunctionSep 30, 2020Complete Loss of Power; Complete Loss of Power

  RELATED MFR NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT HAD A NO EXTERNAL POWER ALARM DUE TO AC LOSS OF POWER. ACCORDING TO THE PATIENT, BOTH MPUS HAVE BEEN WORKING WITHOUT ISSUE. IT WAS REPORTED THAT MPU-103286 HAS A V-LOCK, THE OTHER ACCORDING TO THE PATIENT LOOKS WELL SEATED AT THE CONNECTION. THE PATIENT DID NOT KNOW IF THE POWER CORD CAME LOOSE AT THE WALL/OUTLET OR THE BACK OF THE UNIT. THERE WERE NO REPORTED ENVIRONMENTAL CIRCUMSTANCES THAT COULD HAVE AFFECTED THE A/C POWER AT THE TIME OF THE EVENT. THE PATIENT DID NOT KNOW WHICH MPU THE EVENT HAPPENED ON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10607087 ↗
• MalfunctionJun 23, 2020Electrical Power Problem; Complete Loss of Power; Electrical Power Problem; Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE LOW VOLTAGE ADVISORY ALARMS. LOG FILE ANALYSIS SHOWED SEVERAL OCCURRENCES OF NO EXTERNAL POWER ALARMS WHILE UTILIZING THE MOBILE POWER UNIT AS A POWER SOURCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187093 ↗
• MalfunctionSep 5, 2018Disconnection; Loss of Power; Disconnection; Loss of Power

  DURING INVESTIGATION OF THE COMPLAINT, ANALYSIS OF THE SUBMITTED PATIENT'S SYSTEM CONTROLLER LOG FILE CONFIRMED NO EXTERNAL POWER EVENTS RECORDED ON (B)(6) 2017. THIS COULD BE CAUSED BY THE POWER CORD OF THE MOBILE POWER UNIT (MPU) COMING LOOSE AT THE MPU OR THE WALL OUTLET. DURING THESE EVENTS THE SYSTEM CONTROLLER¿S INTERNAL BACKUP BATTERY PROVIDED POWER TO THE PUMP AS DESIGNED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7845017 ↗
• MalfunctionAug 17, 2018Power Problem; Power Problem

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT THE MANUFACTURER¿S TECHNICAL SERVICES REPRESENTATIVE REVIEWED THE SUBMITTED LOG FILE AND DURING THE ANALYSIS OF THE LOG, IT WAS REPORTED THAT A LOW POWER HAZARD ALARM WAS OBSERVED ON (B)(6) 2018 WHICH MAY BE DUE TO THE MOBILE POWER UNIT (MPU) AC POWER CORD COMING LOOSE AT THE AC POWER CORD MPU CONNECTION OR AC WALL OUTLET. THERE WAS NO INTERRUPTION IN PUMP SUPPORT TO THE PATIENT DURING THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7793790 ↗
• MalfunctionAug 17, 2018Connection Problem; Power Problem; Connection Problem; Power Problem

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THAT WHEN THE PATIENT WAS SEEN AT THE CLINIC, A NO EXTERNAL POWER ALARM WAS OBSERVED IN THE HISTORY FILE UPON INTERROGATION OF THE LVAD SYSTEM. THE PATIENT DID NOT RECALL THE INCIDENT OCCURRING. THERE WAS NO ADVERSE IMPACT TO THE PATIENT REPORTED. A LOG FILE SUBMITTED TO THE MANUFACTURER¿S TECHNICAL SERVICES FOR ANALYSIS CONFIRMED A NO EXTERNAL POWER EVENT RECORDED ON (B)(6) 2018. THIS COULD BE CAUSED BY THE POWER CORD OF THE MOBILE POWER UNIT (MPU) COMING LOOSE AT THE MPU OR THE WALL OUTLET. DURING THESE EVENTS THE SYSTEM CONTROLLER¿S INTERNAL BACKUP BATTERY PROVIDED POWER TO THE PUMP AS DESIGNED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793157 ↗
• MalfunctionJul 17, 2018Loss of Power; Connection Problem; Loss of Power; Connection Problem

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. A LOG FILE SUBMITTED TO THE MANUFACTURER¿S TECHNICAL SERVICES FOR ANALYSIS NOTED A NO EXTERNAL POWER EVENT RECORDED. THIS COULD BE CAUSED BY THE POWER CORD OF THE MPU COMING LOOSE AT THE MPU OR THE WALL OUTLET. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7692983 ↗