THORATEC® HEARTMATE II®, SYSTEM CONTROLLER 106762Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,101 adverse event reports that list this exact device (DI 00813024011286), received between Apr 15, 2016 and Sep 30, 2026 — classified as 6 deaths, 77 injuries, 1,018 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (302 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 9, 2025Class IIOpen, Classified

   Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

   Z-0508-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,101 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951542 ↗
• MalfunctionSep 25, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904536 ↗
• MalfunctionSep 24, 2026Premature Discharge of Battery; Disconnection; Electrical Power Problem

  It was reported that the patient had multiple Low Voltage Advisory Alarms and stated that their Batteries were not draining equally. The Battery connected to the White Cable on the System Controller was draining much faster. The patient cleaned all peripheral equipment and changed their Batteries and Battery Clips, but the alarms did not resolve. The alarms continued to occur on all Batteries and different sets of Battery Clips. Log Files were submitted. Upon review, the HeartMate 2 Log Files recorded 228 Low Battery Advisory Events on 14Sep2026 from 2:27:13PM to 4:32 PM. The Low Battery Hazard Advisory Events were recorded at times when the White Power Lead was disconnected. A root cause for the event was not able to be determined based on the Log Files. Follow-up from the customer reported that the patient's primary Pocket Controller was successfully exchanged and the alarms had resolved. The patient would continue to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888561 ↗
• MalfunctionSep 8, 2026Mechanical Problem

  It was reported that the Log Files were submitted for review. There was a small wire slice noted on black cable of the System Controller. It appeared that the Event Log captured routine events, the VAD and peripheral equipment were functioning as intended. Rescue tape was applied to slice in Driveline Cable. There were no events observed in the Log Files upon review, and the product remained in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669852 ↗
• MalfunctionSep 3, 2026Premature Discharge of Battery; Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599224 ↗
• MalfunctionSep 3, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50590783 ↗
• MalfunctionSep 3, 2026No Audible Alarm; Electrical Power Problem; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50590772 ↗
• MalfunctionFeb 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED TO HAVE A SHORT TO SHIELD AND WAS PLACED ON A LOANER UNGROUNDED CABLE. THE PATIENT WAS IN REHAB WHEN THE NURSING STAFF CLAIMED A DRIVELINE FAULT OCCURRED. THE 11V BATTERY WAS RESEATED AND REPLACED BUT THE ALARM DID NOT CLEAR. IT WAS SUSPECTED THE SYSTEM CONTROLLER NEEDED TO BE EXCHANGED. THE LEFT VENTRICULAR ASSIST DEVICE NUMBERS PRIOR TO THE EXCHANGED SHOWED THE FLOW TO BE AT 11. 4, SPEED AT 9200 RPM, AND PULSATILITY INDEX (PI) AND POWER AT 8.7. THE DRIVELINE WAS THEN DISCONNECTED AND RECONNECTED TO THE ORIGINAL SYSTEM CONTROLLER AND THE DRIVELINE FAULT ALARMS CLEARED IMMEDIATELY. THE PATIENT'S FLOW RETURNED TO BASELINE AT 5.5 LPM, SPEED AT 9200 RPM, PI AT 4.4 AND POWER AT 5.7. UPON INITIAL INTERROGATION IT WAS CONFIRMED THAT THE PATIENT HAD DRIVELINE FAULT ALARMS WHERE FLOWS WERE AS HIGH AS 12, PI WAS 3.2 AND POWER AT THE TIME OF THE INITIAL ALARM WAS 9.4. THE BACKUP SYSTEM CONTROLLER WAS ALSO CHECKED, AND IT APPEARED THAT THE CLOCK WAS NOT SET. THE CLOCK WAS THE SET, THEN THE SINGLE SYSTEM CONTROLLER EXCHANGE WAS PERFORMED. THE TRANSITION INITIALLY WENT WELL, HOWEVER AFTER APPROXIMATELY 12 SECONDS THE PATIENT STATED THEY DIDN'T FEE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474814 ↗
• MalfunctionFeb 11, 2026Mechanical Problem

  THE CAUSE OF THE DAMAGE WAS NOT AVAILABLE. IT WAS NOTED THAT THIS EVENT DID NOT CREATE ANY ALARMS. THERE WAS NOT CONCERN ABOUT A FAILURE TO ALARM BY THE CONTROLLER. THE CONTROLLER WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315481 ↗
• MalfunctionFeb 3, 2026Electrical Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BACKUP BATTERY FAULTS FREQUENTLY OVER THE PAST YEAR AND MORE. INITIALLY, IT WAS TO HAVE CLEARED WITH THE COMPLETION OF A SELF-TEST, BUT SINCE SUMMER OF 2025, THE PATIENT HAD NEEDED A NEW 11V BATTERY, WHICH WERE ISSUED OUTSIDE OF THE 36-MONTH ROTATION AND WAS SAID TO HAVE RECEIVED REPLACEMENTS IN (B)(6) 2025 AND AGAIN IN (B)(6) 2025 (B)(6). THE BACKUP BATTERY FAULT RECURRED IN (B)(6) 2026 AND INITIALLY RESOLVED WHEN THE PATIENT PLUGGED INTO THE POWER MODULE (PM), DESPITE EDUCATION TO REMAIN ON BATTERY POWER. IT WAS SAID TO HAVE RECURRED AGAIN AND HAS BEEN PERSISTENT FOR THE PAST WEEK AND MORE. THE PRIOR ALARM RESOLVED ON (B)(6) 2026. THE PATIENT HAS HAD A KNOWN INTERNAL DRIVELINE FRACTURE AND HAD A DRIVELINE REPAIR UP TO VELOUR IN THE PAST. THE PATIENT HAS ALSO BEEN ISSUED A NEW POCKET CONTROLLER IN (B)(6) 2023 (B)4). THE EMERGENCY BACKUP BATTERY (EBB) FAULTS WERE SAID TO NO BE RELATED TO THE DRIVELINE. IT WAS RECOMMENDED TO REPLACE THE SYSTEM CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254449 ↗
• MalfunctionJan 26, 2026Electrical /Electronic Property Problem; Infusion or Flow Problem

  MORE RECENT LOG FILES WERE SUBMITTED, AND THEY CAPTURED MULTIPLE LOW SPEED AND PUMP STOP ALARMS ON (B)(6) 2026 WHILE THE PATIENT WAS CONNECTED TO THE POWER MODULE. THIS INDICATED THAT THE REPAIR ON (B)(6) 2026 DID NOT REMOVE THE DAMAGED AREA AND IS LIKELY INTERNAL. THE PATIENT WOULD RECEIVE AN UNGROUNDED CABLE TO PREVENT ALARMS. THE PATIENT WAS ON BATTERY POWER AND WAS DOING OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179651 ↗
• MalfunctionJan 21, 2026Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE PATIENT'S BACKUP SYSTEM CONTROLLER HAD TO BE CHANGED DUE TO DAMAGE TO THE WHITE CORD. LOG FILES WERE UNABLE TO BE PULLED AS IT COULD NOT BE CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137945 ↗
• MalfunctionJan 16, 2026Circuit Failure; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE ALARMS NOTED IN THEIR HISTORY, BUT NO AUDIBLE ALARMS AT HOME. LOG FILES WERE SENT FOR REVIEW. THE LOG CAPTURED 157 DRIVELINE FAULT ALARMS BETWEEN ON (B)(6) 2025 AND ON (B)(6) 2026. THE BLACK WIRE APPEARED TO BE PARTIALLY DAMAGED. X-RAY IMAGES SHOWED A FEW SUSPECT AREAS. THERE APPEARED TO BE SOME THINNING AND/OR BENDS IN THE DRIVELINE. THE DRIVELINE WAS REPAIRED. THERE WERE NO ACTIVE ALARMS AT TIME OF REPAIR. VISUAL INSPECTION NOTED COMPRESSION AND BENDING OF THE DRIVELINE NEAR THE EXIT SITE, AS WELL AS RESCUE TAPE COVERING THE FULL LENGTH OF THE DRIVELINE. TECH SERVICES REMOVED REMAINING OUTER LAYER AND BIONATE. THE SHIELDING WAS COMPLETELY OXIDIZED AND FELL OFF IMMEDIATELY AFTER REMOVING BIONATE. BROKEN BLACK WIRE WAS DISCOVERED APPROXIMATELY 3" FROM EXIT SITE. THERE WAS NOTED DAMAGE TO GREEN WIRE AS WELL IN THE SAME AREA. BLACK, RED, AND YELLOW WIRES WERE SPLICED. DURING SPLICING OF YELLOW WIRE, GREEN WIRE BROKE AND SHORTED THE SYSTEM CONTROLLER. THE PATIENT REMAINED STABLE. THEY WERE SWAPPED OVER TO NEW DRIVELINE AND BACKUP CONTROLLER. TECH SERVICES CONTINUED SPLICING GREEN, BROWN, AND ORANGE WIRES. THE AREA WAS CLOSED UP PER PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092762 ↗
• MalfunctionJan 13, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DRIVELINE FAULT ALARMS ON 03DEC2025 LASTED FOR 3 HOURS. THE PATIENT REPORTED TO BE DOING WELL, DENIED ANY HEART FAILURE (HF) SYMPTOMS OR ALARMS. THE LOG FILES WERE SUBMITTED FOR REVIEW. IT APPEARED THAT THE LOG FILE CAPTURED DRIVELINE FAULT EVENTS ON 03DEC2025 THAT ARE INTERMITTENT AND MAY POSSIBLY INDICATE AN ISSUE WITH ONE OF THE SIX DRIVELINE WIRES. ADDITIONALLY, HEARTMATE II LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILE CAPTURED THE SYSTEM CONTROLLER EXCHANGE. THE LOG FILE DID NOT CAPTURE ANY ADDITIONAL DRIVELINE FAULTS. THE CLINICIAN REPORTED THAT THE SUBMITTED X-RAYS DID NOT SHOW ANY AREAS OF CONCERN. THEY REPORTED NO FURTHER ALARMS SINCE LAST CLINIC VISIT. THEY CHANGED BOTH THE SYSTEM CONTROLLERS, AS THE PATIENT TOLERATED THE EXCHANGE. THEY DID THE MULTIPLE DISCONNECTIONS AND OBTAINED LOG FILES. THEY NOTED (B)(6) WAS THE PRIMARY SYSTEM CONTROLLER DURING THE DRIVELINE FAULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059230 ↗
• MalfunctionJan 2, 2026Electrical Power Problem

  IT WAS REPORTED THAT THERE WAS A RECURRING BACKUP BATTERY (EBB) FAULT. THIS WAS THE SECOND FAULT THAT HAS OCCURRED AFTER THE EBB WAS REPLACED RECENTLY. THE SYSTEM CONTROLLER WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944631 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LAST DOCUMENTED SYSTEM CONTROLLER EXCHANGE WAS (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780614 ↗
• MalfunctionDec 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE SYSTEM CONTROLLER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE SITE KEPT THE CONTROLLER SO IT COULD BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780511 ↗
• MalfunctionDec 9, 2025Device Difficult to Setup or Prepare; Electrical Power Problem; Device Difficult to Setup or Prepare; Electrical Power Problem

  IT WAS REPORTED THAT THE LOG FILES WERE SUBMITTED FOR EVALUATION CONCERNING BACKUP BATTERY FAULTS. THE PATIENT REPLACED THE EMERGENCY BACKUP BATTERY (EBB) AT VISIT ON (B)(6) 2025 DUE TO THE EBB EXPIRING. WHEN THE PATIENT TRIED TO CHARGE THE SYSTEM CONTROLLER AT HOME, AN EBB FAULT ALARM OCCURRED. THIS ALSO OCCURRED AS WELL AT THE CLINIC ONCE PLUGGED INTO MONITOR. THE CONTROLLER WAS PLUGGED INTO THE MONITOR TO GET THE ATTACHED WAVE FORMS AND THE SYSTEM CONTROLLER AND BATTERY WERE RESYNCED. EBB FAULTS WERE STILL PRESENT FOLLOWING THIS. THE BACKUP CONTROLLER WAS EXCHANGED, AND THE EXCHANGED CONTROLLER WAS INTENDED TO RETURN FOR EVALUATION. THE BATTERY WAS PLUGGED IN AND THERE WAS AN ATTEMPT TO GET THE PINS INSERTED BUT THEY WOULD NOT FULLY CLICK AFTER TRYING TO GET NEW BATTERY FROM 14NOV2025 SEATED CORRECTLY. LOG FILES INDICATED THAT THE FAULTS ASSOCIATED WITH THE EBB WAS A BACKUP BATTERY UNINSTALLED AND A BACKUP BATTERY SIGNAL FAULT. THESE EVENTS HAD BEEN INTERMITTENTLY ACTIVE SINCE (B)(6) 2025. THESE EVENTS INDICATED THAT THE EBB WAS NOT PROPERLY CONNECTED TO THE SYSTEM CONTROLLER OR THERE WAS AN ISSUE WITH THE EBB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760475 ↗
• MalfunctionDec 9, 2025Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  IT WAS ADDITIONALLY REPORTED THAT THERE WAS NO INFORMATION FOR MITRAL INSUFFICIENCY. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED. THE DEVICE OPERATED AS EXPECTED. X-RAY OF DRIVELINE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759212 ↗
• MalfunctionDec 8, 2025Mechanical Problem; Device Difficult to Setup or Prepare; Mechanical Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THE PATIENT HAD GREEN DRAINAGE FROM THE CABLE WHICH CONNECTS FROM POWER TO THE DRIVELINE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT, WHERE A SYSTEM CONTROLLER EXCHANGE WAS ATTEMPTED, HOWEVER THE RED BUTTON TO RELEASE THE DRIVELINE WAS STUCK. DESPITE ATTEMPTING TO MANIPULATE THE SYSTEM CONTROLLER AND INCREASE PRESSURE, THE SITE WAS UNABLE TO PERFORM A SYSTEM CONTROLLER EXCHANGE. LOG FILE REVIEW WAS REQUESTED WHICH SHOWED NO UNUSUAL EVENTS. ON (B)(6) 2025, THE SYSTEM CONTROLLER WAS DISASSEMBLED IN ORDER TO ACCESS THE LOCKING MECHANISM. THE DRIVELINE GROMMET WAS REMOVED TO BETTER APPLY ALCOHOL TO LOOSEN UP THE DRIVELINE CONNECTOR. THE DRIVELINE WAS REMOVED AND RECONNECTED TO A NEW SYSTEM CONTROLLER. THE PUMP RESUMED NORMAL OPERATION. THERE WAS NO ADVERSE PATIENT IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745086 ↗
• MalfunctionDec 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE LVAD ALARMS GOING OFF ON (B)(6) 2025. THROUGH LOG FILES ANALYSIS, TECH SERVICES FOUND A PUMP OFF EVENT AT 11:13:59, FOLLOWED BY A PUMP OFF, DRIVELINE DISCONNECT, AND LOW FLOW ALARM AT 11:14:00. PATIENT CARE STAFF CHANGED THE CONTROLLER BATTERIES, WHICH DID NOT RESOLVE ALARMS. PATIENT CARE STAFF THEN EXCHANGED THE CONTROLLER, WHICH DID RESOLVE ALARMS. IT WAS LATER REPORTED THAT THE CAUSE OF THE LOW FLOW ALARM, PUMP OFF ALARM, AND DRIVELINE DISCONNECT WERE NOT IDENTIFIED. IT WAS ALSO LATER REPORTED THAT THE PATIENT EXPERIENCED BRIEF NON-TRAUMATIC SYNCOPE DURING THE CONTROLLER EXCHANGE. IT WAS LATER REPORTED THE PATIENT EXPERIENCED ANOTHER CONTROLLER ALARM ON (B)(6) 2025. THE PATIENT'S WIFE INSPECTED THE CONTROLLER AND FOUND THE DRIVELINE'S BACKDOOR SLID OUT OF ITS "LOCKED" CONFIGURATION, THINKING THE PATIENT MAY HAVE BEEN FIDGETING WITH THE MECHANISM. TECH SERVICES REVIEWED LOG FILES BUT FOUND NO ALARMS CORRELATING WITH THE ON (B)(6) 2025 EVENT. LOG FILE REVIEW DID CAPTURE A DOUBLE POWER CABLE DISCONNECT EVENT ON 08SEP2025 15:04. THERE WAS NO PUMP INTERRUPTION AND THE EBB FUNCTIONED AS INTENDED. ALARMS RESOLVED WHEN BATTERY POWER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731105 ↗
• MalfunctionDec 1, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE POWER CABLE DISCONNECTS ORIGINATING FROM THE BLACK CONTROLLER POWER CABLE. PATIENT ALSO REPORTEDLY HAD DIZZINESS, HIGH FLOW AND HIGH POWER ON (B)(6) 2025. THEY WERE OTHERWISE ASYMPTOMATIC. LOG FILES WERE SUBMITTED FOR REVIEW. LOG FILE REVIEW BY TECH SERVICES CONFIRMED NUMEROUS POWER CABLE DISCONNECTS ON (B)(6) 2025 ON THE WHITE POWER CABLE WHILE CONNECTED TO BATTERY POWER, AND NUMEROUS POWER CABLE DISCONNECTS ON (B)(6) 2025 ON THE BLACK POWER CABLE WHILE ON BATTERY POWER. NO ALARMS OCCURRED WHILE CONNECTED TO THE POWER MODULE. LOG FILE REVIEW DID NOT APPEAR TO CAPTURE ANY NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES, AND THAT THE MCS EQUIPMENT WAS OPERATING AS INTENDED ELECTRONICALLY AND MECHANICALLY. IT WAS LATER REPORTED THAT THE REPORTED ISSUE WAS CAUSED BY PROBLEMS WITH THE CONTROLLER OR BATTERY CLIPS. THE PATIENT HAD BOTH PRIMARY AND BACKUP CONTROLLER EXCHANGED AND WAS GIVEN A NEW SET OF BATTERIES AND BATTERY CLIPS. THERE WAS NO DOCUMENTED REASON FOR THE BACKUP CONTROLLER TO ALSO BE EXCHANGED, BUT THE CONTROLLER, BATTERY, AND BATTERY CLIP EXCHANGES RESOLVED ALL ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689424 ↗
• MalfunctionDec 1, 2025Display or Visual Feedback Problem; Complete Loss of Power; Display or Visual Feedback Problem; Complete Loss of Power

  IT WAS REPORTED THAT A PATIENT, WHO USES AN UNGROUNDED CABLE DUE TO A HISTORY OF SHORT TO SHIELD, HAD A "LOSS OF EXTERNAL POWER" ALARM WHILE CONNECTED TO THE POWER MODULE. THE PATIENT THEN SWITCHED TO THEIR BATTERIES. WHEN THE PATIENT WAS ON THE PHONE WITH THE CLINIC, THE CLINIC HAD THE PATIENT SWITCH ONE SYSTEM CONTROLLER POWER CABLE TO THE POWER MODULE AND THE ALARM REOCCURRED. THIS WAS THE SAME FOR BOTH THE WHITE AND BLACK POWER LEADS. THE PATIENT PRESENTED TO THE CLINIC AND WAS CONNECTED TO THE POWER MODULE IN THE CLINIC BUT ON THEIR UNGROUNDED CABLE. LOG FILES WERE SUBMITTED FOR REVIEW AND RECORDED UNUSUAL VOLTAGES CONNECTED TO POWER MODULE, THE MOTOR FUNCTION WAS NOT AFFECTED BY THIS EVENT. IT WAS PLANNED TO EXCHANGE THE POWER MODULE AND REPLACE THE UNGROUNDED PATIENT CABLE. IT WAS ALSO NOTED THAT THE SYSTEM CONTROLLER HAD A DIM PUMP RUNNING SYMBOL AND THE SYSTEM CONTROLLER WOULD BE EXCHANGED. THE SYSTEM CONTROLLER WAS EXCHANGED, AND LOG FILES WERE SUBMITTED FOR REVIEW WHICH CAPTURED NO UNUSUAL EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682267 ↗
• MalfunctionNov 25, 2025Mechanical Problem; Electrical Power Problem; Mechanical Problem; Electrical Power Problem

  IT WAS REPORTED THAT A GREEN SMUDGE WAS NOTICED ON THE PATIENT'S WHITE POWER CABLE. CONTROLLER INTERROGATION APPEARED TO CAPTURE ONE LOW VOLTAGE ADVISORY EVENT. THE CONTROLLER HAS BEEN EXCHANGED AND AVAILABLE FOR EVALUATION. LOG FILES WERE SENT TO TECH SERVICES FOR REVIEW. LOG FILES CONTAINED ROUTINE POWER SOURCE CHANGES. NO ABNORMAL ALARMS OR EVENTS WERE RECORDED, AND THE PUMP APPEARED TO BE OPERATING AS INTENDED. THE REPORTED GREEN SLUDGE APPEARED TO BE COSMETIC IN NATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649762 ↗
• MalfunctionNov 21, 2025Electrical /Electronic Property Problem; Insufficient Device Problem Information; Electrical /Electronic Property Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE POWER CABLE DISCONNECTS ORIGINATING FROM THE BLACK CONTROLLER POWER CABLE. PATIENT ALSO REPORTEDLY HAD HIGH FLOW AND HIGH POWER ON (B)(6) 2025. LOG FILES WERE SUBMITTED FOR REVIEW. LOG FILE REVIEW BY TECH SERVICES CONFIRMED NUMEROUS POWER CABLE DISCONNECTS ON (B)(6) 2025 ON THE WHITE POWER CABLE WHILE CONNECTED TO BATTERY POWER, AND NUMEROUS POWER CABLE DISCONNECTS ON (B)(6) 2025 AND (B)(6) 2025 ON THE BLACK POWER CABLE WHILE ON BATTERY POWER. NO ALARMS OCCURRED WHILE CONNECTED TO THE POWER MODULE. LOG FILE REVIEW DID NOT APPEAR TO CAPTURE ANY NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES, AND THAT THE MCS EQUIPMENT WAS OPERATING AS INTENDED ELECTRONICALLY AND MECHANICALLY. IT WAS LATER REPORTED THAT THE REPORTED ISSUE WAS CAUSED BY PROBLEMS WITH THE CONTROLLER OR BATTERY CLIPS. THE PATIENT EXPERIENCED DIZZINESS ON (B)(6) 2025, OTHERWISE ASYMPTOMATIC. THE PATIENT HAD BOTH PRIMARY AND BACKUP CONTROLLER EXCHANGED FOR THIS EVENT AND GIVEN A NEW SET OF BATTERIES AND BATTERY CLIPS. IT WAS LATER REPORTED ON (B)(6) 2025 THERE WAS NO DOCUMENTED REASON FOR THE BACKUP CONTROLLER TO ALSO BE EXCHANGED, BUT THE CONTROLLER, BATTERY, AND BATTERY CLIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622032 ↗