THORATEC® HEARTMATE®, SYSTEM MONITOR 1286Recalls & reported problems

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 00813024010142), received between Sep 9, 2019 and Oct 23, 2025 — classified as 4 injuries, 226 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (149 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. May 8, 2024Class IOpen, Classified

   System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

   Z-1921-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE WAS A PUMP STOP; 0 FLOW RED ADVISORY ALARM DISPLAYED ON SYSTEM MONITOR BUT FLOW AND SPEED WAS THERE UNDER THE PUMP FLOW. SYSTEM CONTROLLER FLOW AND SPEED WERE ALSO CHECKED WHICH WERE SHOWING. THE SYSTEM MONITOR WAS RESTARTED AND THAT RESOLVED THE ISSUE. THE PATIENT WAS STABLE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT. NO UNUSUAL EVENTS WERE SEEN IN THE LOG FILES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372222 ↗
• MalfunctionOct 17, 2025Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC DUE TO NOTICING THAT THEIR MONITOR SCREEN WAS LIT RED AND CLAIMED THAT THEIR PUMP WAS NOT WORKING AND HAVING LOW FLOWS. THERE WERE NO ALARMS ACTIVE ON THE SYSTEM CONTROLLER AT THE TIME. THE GREEN PUMP RUNNING LIGHT WAS ON AND THE PATIENT WAS SWITCHED TO BATTERIES. THE BEDSIDE NURSE THEN SHUT THE MONITOR DOWN AND TURNED IT BACK ON. WHEN PLACED BACK TO THE POWER MODULE THE MONITOR SCREEN WAS NO LONGER RED. UPON INITIAL INTERROGATION, A LOW VOLTAGE ADVISORY WAS NOTED, BUT NO LOW FLOW ALARMS OR PUMP STOP ALARMS WERE SEEN. LOG FILES WERE SUBMITTED FOR FURTHER REVIEW AND CAPTURED TWO LOW FLOW EVENTS ON 29SEP2025 AT 15:09:29 AND 15:09:33. THE CALCULATED FLOW APPEARED TO HAVE FLUCTUATED BELOW THE ALARM THRESHOLD OF 2.5 LPM DURING THE EVENTS. THE LOG FILE CONTAINED ONLY TWO LOW FLOW ESTIMATES WHEN THE CALCULATED PULSATILITY INDEX WAS DYNAMIC AND ELEVATED. THE LOW FLOW READINGS DID NOT APPEAR TO BE THE RESULT OF ANY EXTERNAL EQUIPMENT MALFUNCTION. THE EVENT LOG FILE DATE RANGE WAS FROM 27SEP2025 TO 30SEP2025, AND NO ADVERSE EVENTS WERE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325904 ↗
• MalfunctionJul 31, 2025Pumping Stopped; Improper or Incorrect Procedure or Method; Pumping Stopped; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION WAS PROVIDED ON 29JUL2025 THAT THE PUMP STOP WAS UNINTENTIONAL AND DUE TO USER ERROR. THERE WAS NO IMPACT TO PATIENT DUE TO THE PUMP STOP AND THE PATIENT REMAINED IN THE HOSPITAL AND WOULD BE DISCHARGED SOON.

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

  MAUDE report 22682514 ↗
• MalfunctionMar 31, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR WAS DISPLAYING PREVIOUS SOFTWARE WAS NOT COMPLETED, INSERT SOFTWARE CARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733573 ↗
• MalfunctionMar 19, 2025Display or Visual Feedback Problem; Device Displays Incorrect Message; Display or Visual Feedback Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENTS SYSTEM MONITOR WHILE CONNECTED TO THE SYSTEM CONTROLLER DISPLAYED THAT THE PUMP WAS OFF. THE PATIENT'S CONDITION WAS DESCRIBED AS FINE, AND NO AUDIBLE OR VISUAL ALARMS WERE FOUND. THE CENTER BELIEVED THIS WAS A SYSTEM MONITOR DISPLAY ISSUE. IT WAS RECOMMENDED THAT THE CENTER POWER CYCLE THE SYSTEM MONITOR TO RESOLVE THE ISSUE, AND IF THE ISSUE WERE TO PERSIST, TO TAKE THE SYSTEM MONITOR OUT OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646313 ↗
• MalfunctionMar 3, 2025Display or Visual Feedback Problem; Pumping Stopped; Display or Visual Feedback Problem; Pumping Stopped

  IT WAS REPORTED THAT THE PATIENT HAD A LOW FLOW AND PUMP STOP OVERNIGHT. IT WAS UNCLEAR AS TO WHY THIS HAPPENED. THERE WAS INITIAL CONCERN THAT IT WAS DUE TO THE SYSTEM MONITOR. THE EVENT LOG CAPTURED THE PUMP STOP THAT WAS REPORTED ON (B)(6) AT 01:08 WHILE USING THE POWER MODULE. IT APPEARED THAT THE PUMP STOP BUTTON WAS PRESSED ON THE MONITOR THAT RESULTED IN THE BRIEF 2 SECOND PUMP STOP. THE LOG SHOWED "INTENTIONAL PUMP STOP." NO OTHER UNUSUAL EVENTS WERE NOTED IN THE LOG. THE PATIENT'S LEFT VENTRICULAR ASSIST DEVICE (LVAD) CONSOLE SCREEN WAS GLITCHED AND THE CUSTOMER WAS UNABLE TO TOUCH THE SCREEN WITHOUT THE LVAD ALARMING. THE PATIENT SWITCHED TO BATTERY POWER AND WERE STILL FLOWING ON THE SYSTEM CONTROLLER. THE CUSTOMER UNPLUGGED THE CURRENT CONSOLE, BUT IT DID NOT RESOLVE THE ISSUE. THE PATIENT WAS STILL INPATIENT. IT WAS UNKNOWN IF THE SYSTEM MONITOR WAS REBOOTED BEFORE USE. NO PRODUCTS WOULD BE RETURNED. LOG FILES SHOWED THAT THE LOW FLOW ALARMS WERE SECONDARY TO PUMP BEING STOPPED. THE PATIENT HAD NO FURTHER LOW FLOW ALARMS. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF LOW FLOWS. THE PATIENT DID NOT TOUCH ANYTHING ON THE MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21508103 ↗
• MalfunctionFeb 18, 2025Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6)2024 DUE TO WORSENING ARRHYTHMIA SYMPTOMS. THE ARRHYTHMIA WAS CONTROLLED; HOWEVER, THE PATIENT REMAINED HOSPITALIZED AND UNDERWENT FURTHER EXAMINATION AS LOW FLOW WAS LIKELY TO OCCUR. ON (B)(6)2024, SYMPTOMS OF A PULMONARY EMBOLISM WERE NOTED, AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS PERFORMED WHICH WAS NOTED TO BE STILL ONGOING. DURING ECMO MANAGEMENT THE HEARTMATE 3 WAS BARELY WORKING, WITH FLOW BEING 0-0.4 LITERS PER MINUTE AND LOW FLOWS CONSTANTLY ACTIVE. WHEN THE HISTORY WAS CHECKED ON THE SYSTEM MONITOR, IT DISPLAYED "NO RECORDS OBTAINED," SO IT WAS DECIDED TO CHECK WHETHER THE SYSTEM WAS OPERATING NORMALLY. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED LOW FLOW ALARM EVENTS ON (B)(6)2024 THAT OCCURRED AT TIMES WHEN PULSATILITY INDEX (PI) WAS ELEVATED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED PERSISTENT VENTRICULAR FIBRILLATION REQUIRING DEFIBRILLATION OR CARDIOVERSION ON (B)(6)2024, WAS ADMITTED ON (B)(6)2024 AND HAD A HISTORY OF ARRHYTHMIA PRIOR TO IMPLANT ALONG WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ARRHYTHMIA WAS NOT THOUGHT TO BE DEVICE OR THERAPY REL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396741 ↗
• MalfunctionJan 27, 2025Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT WHEN SWITCHING ON THE SYSTEM MONITOR, THE DISPLAY DID NOT BOOT CORRECTLY. REBOOTING THE SYSTEM MONITOR DID NOT SOLVE THE ISSUE. THE DISPLAY SHOWED EITHER JUST COLORED PIXELS OR BLURRED LINES. THE SYSTEM MONITOR WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240706 ↗
• MalfunctionJan 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR SCREEN WOULD FREEZE AT TIMES. THE SYSTEM MONITOR WAS NO LONGER SERVICEABLE AND WAS AN OBSOLETE PRODUCT. THE CUSTOMER PLANNED ON OBTAINING A PATIENT CABLE AND SYSTEM CONTROLLER TO TRY TO DO SOME TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114673 ↗
• MalfunctionOct 23, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR II HAD NO TOUCH RESPONSE. THE SYSTEM MONITOR WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517076 ↗
• MalfunctionOct 14, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THE PATIENT'S LOG FILES WERE SUBMITTED FOR INTERROGATION DUE TO A PUMP STOP EVENT, WHICH OCCURRED SOMETIME ON 23SEP2024. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE PUMP OFF EVENT. THE PATIENT WAS TO CONTINUE WITH NORMAL POST OPERATIVE CARE. FOLLOWING REVIEW OF THE SUBMITTED LOG FILES BY TECH SERVICES, IT APPEARED THERE WAS A PUMP STOP EVENT ON 23SEP2024 AT 15:32 DUE TO AN INTENTIONAL PUMP STOP BEING ACTIVATED ON THE SYSTEM MONITOR. THERE WERE NO OTHER UNUSUAL EVENTS IN THE LOG FILE EVENT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441363 ↗
• MalfunctionOct 10, 2024No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CONNECT POWER ALARM WHILE ON BATTERY POWER. THE CLIPS AND BATTERIES WERE EXCHANGED BUT THIS DID NOT RESOLVE THE ALARM. THE PATIENT WAS PLACED ON THE POWER MODULE AND NO DATA WAS DISPLAYED ON THE SYSTEM MONITOR. IT WAS SUSPECTED THAT A WIRE ON THE WHITE POWER LEAD OF THE SYSTEM CONTROLLER WAS FRACTURED. THE SYSTEM CONTROLLER WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423560 ↗
• MalfunctionOct 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PUMP PARAMETERS WERE NOT DISPLAYING ON THE SYSTEM MONITOR. THE PATIENT WAS CONNECTED TO THE SYSTEM MONITOR, BUT THE MONITOR WAS NOT REGISTERING THAT THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS CONNECTED, AND THE CLINICIAN WAS UNABLE TO COMPLETE INTERROGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407838 ↗
• MalfunctionOct 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS UNKNOWN IF THE SYSTEM MONITOR WAS REBOOTED BEFORE USE. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS ADVERSE EFFECTS DUE TO THE EVENT. IT WAS UNKNOWN IF REBOOTING THE SYSTEM MONITOR RESOLVED THE ISSUE. THE BEDSIDE NURSES ERRONEOUSLY ATTEMPTED TO DETERMINE ALARMS BY REVIEWING ALL POTENTIAL ALARMS ON THE MONITOR. THERE WERE NO IDENTIFIABLE ALARMS ASSOCIATED WITH REPORTED EVENTS. THE PATIENT HAD NO HEMODYNAMIC COMPROMISE. THE VAD COORDINATOR REVIEWED HISTORY IN DETAIL AND REPORTED EVENTS LIKELY DUE TO INACCURATE ATTEMPTS AT INTERROGATION BY BEDSIDE NURSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350774 ↗
• MalfunctionSep 13, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THE SYSTEM MONITOR DID NOT RESPOND TO TOUCH FOR ROUTINE PARAMETER CHECK. DURING TROUBLESHOOTING, THE MONITOR WAS FOUND TO OPERATE NORMALLY. THE SITE WAS ADVISED TO REBOOT THE MONITOR IF THE ISSUE RETURNED OR TO REPLACE THE MONITOR IF THE ISSUE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215122 ↗
• MalfunctionSep 11, 2024Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  IT WAS REPORTED THAT SYSTEM MONITOR WAS SHOWING MESSAGE ON SCREEN PREVIOUS SOFTWARE UPGRADE WAS INCOMPLETE INSERT SOFTWARE CARD IN MEMORY SLOT AND TOUCH SCREEN TO CONTINUE. TURN MONITORS OFF, UNPLUGGED FROM POWER MODULE. THE SYSTEM MONITOR WAS TURNED OFF AND UNPLUGGED FROM POWER MODULE. THEN, IT WAS PLUGGED BACK INTO POWER MODULE AND POWERED BACK ON. IT WAS ADVISED TO REMOVE THE SYSTEM MONITOR FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193468 ↗
• MalfunctionSep 4, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT A RENTAL SYSTEM MONITOR LOCATED IN THE SITES STORAGE AREA WAS NOT ILLUMINATING DESPITE POWER BEING DELIVERED TO THE SYSTEM (GREEN LIGHT ILLUMINATED AND 3 BEEPS WERE HEARD). THE MONITOR WAS TURNED ON AND OFF, A NEW POWER CABLE WAS USED, AND A NEW POWER MODULE WAS USED BUT THE PROBLEM PERSISTED. A NEW MONITOR WAS TO BE SENT TO REPLACE THE CURRENT RENTAL UNIT. THE SITE COMMUNICATED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PRODUCT WAS SENT BACK FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138446 ↗
• MalfunctionSep 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PHENOMENON OCCURRED IN WHICH AN HCT IS NOT DISPLAYED ON THE SYSTEM MONITOR. THE SYSTEM MONITOR WAS RESTARTED SEVERAL TIMES BUT DID NOT SEEM TO IMPROVE. A REQUEST FOR LOG FILE ANALYSIS WAS MADE TO CONFIRM THAT THERE WAS NO ABNORMAL ALARM AND PUMP DRIVE. THE HEMATOCRIT VALUE WAS UNKNOWN AND WAS NOT VALIDATED WITH OTHER SYSTEM MONITORS BECAUSE IT WAS NOT REPRODUCIBLE, SO THE STATUS WAS BEING MONITORED. THE SYSTEM MONITOR WAS NOT REPLACED. LOG FILES WERE SUBMITTED FOR REVIEW, AND IT SEEMED THE HEMATOCRIT WAS RECENTLY ADJUSTED IN THE EVENT FILE, BUT THE PERIODIC FILE HAD NOT COLLECTED A NEW SAMPLE OF DATA YET TO SHOW THE ADJUSTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125365 ↗
• MalfunctionAug 15, 2024Pumping Stopped; Pumping Stopped

  IT WAS COMMUNICATED ON (B)(6) 2024 THAT IT WAS UNKNOWN WHY THE PUMP STOP BUTTON WAS PUSHED. THERE WAS NO CHANGE IN PATIENT STATUS, AND NO EQUIPMENT WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995251 ↗
• MalfunctionAug 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT WHEN THE PUMP SPEED WAS SET TO THE LOWER SPEED LIMIT AT 8000 RPM THE SYSTEM MONITOR WOULD NOT WORK AND IT COULD NOT SEND INFORMATION TO THE PUMP. IF THE SPEED WAS ABOVE 8000 RPM, THE DEVICE OPERATED AS EXPECTED. THE ISSUE WAS OBSERVED WHEN TESTED AGAINST TWO DIFFERENT MONITORS, SO IT WAS BELIEVED THAT THERE WAS AN ISSUE WITH THE POWER MODULE. THE SYSTEM MONITOR WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991600 ↗
• MalfunctionJul 31, 2024Display or Visual Feedback Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR SHOWED NO DATA RECEIVED ON SCREEN WHEN CONNECTED TO THE SYSTEM CONTROLLER. TROUBLESHOOTING WOULD BE PERFORMED WITH THE PATIENT CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19872714 ↗
• MalfunctionJul 22, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PATIENT HAD NO ALARMS ON INTERROGATION OF THEIR LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2024, BUT WHEN THE COORDINATOR WENT INTO SETTINGS TAB, THE SCREEN DISPLAYED PUMP OFF, LOW FLOW, AND SYSTEM MONITOR RAM ERROR. THE COORDINATOR STATED THAT THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) HAD JUST BEEN TAKEN AND WAS 87. THE PATIENT WAS ALERT AND ORIENTED AND THEIR VAD HUM WAS AUSCULTATED. THERE WAS NO AUDIBLE ALARM. THE PATIENT WAS TRANSITIONED TO BATTERY POWER FOR A FEW MINUTES, AND THEN BACK TO POWER MODULE AT WHICH TIME THE SETTINGS SCREEN WENT BACK TO NORMAL WITHOUT THE PUMP OFF AND LOW FLOW NOTIFICATION. LOG FILE REVIEW WAS REQUESTED, AND THE LOG FILE DID NOT CONTAIN ANY PUMP STOPS. THE LOG FILE DID CAPTURE A FEW ROUTINE POWER CABLE DISCONNECTS. TECHNICAL SERVICES STATED THAT THE SYSTEM MONITOR DOES HAVE A HISTORY OF OCCASIONALLY DISPLAYING FALSE INFORMATION AND IT WAS RECOMMENDED TO REBOOT THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800105 ↗
• MalfunctionJul 17, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THERE WAS A PUMP OFF ALARM AT 09:00 ON (B)(6) 2024. THE ALARM WAS LESS THAN A SECOND LONG AND STILL POPULATED WITH FLOWS AND POWERS. NEITHER PATIENT NOR NURSE RECALLED HEARING THE ALARM AND THE PATIENT WAS SITTING IN BED HOOKED UP TO AC POWER AT THE TIME. THERE WAS NO CLINICAL REASON FOR THE PUMP TO TURN OFF. LOG FILES CAPTURED LOW FLOW EVENTS ON 25JUN2024. THE LOG ALSO CAPTURED AN INTENTIONAL PUMP STOP ON (B)(6) 2024 AND OTHER ASSOCIATED ALARM TYPES. THIS WAS CAUSED BY THE PUMP STOP BUTTON ON THE SYSTEM MONITOR BEING BRIEFLY ACTIVATED. IT WAS UNKNOWN WHY THE PUMP STOP BUTTON WAS PRESSED ON THE SYSTEM MONITOR. THE PATIENT WAS STABLE; PLAN WAS TO CONTINUE GUIDELINE-DIRECTED MEDICAL THERAPY FOR HEART FAILURE AND MAINTAIN CURRENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19765532 ↗
• MalfunctionJul 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT FREQUENT ERRORS WERE NOTED IN THE SYSTEM MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745628 ↗
• MalfunctionJun 28, 2024Display or Visual Feedback Problem; Data Problem; Display or Visual Feedback Problem; Data Problem

  IT REPORTED THAT A RARE EXPERIENCE OCCURRED WHERE THE PATIENT WAS ON AN OLD SYSTEM MONITOR AND THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) READINGS WERE SPEED: 5000; FLOW: 0; POWER: 0; PI: 0. THE PATIENT WAS ASYMPTOMATIC, AND THE PUMP WAS AUDIBLY RUNNING PER AUSCULTATION. PHOTOS WERE UNAVAILABLE, HOWEVER TURNING THE SCREEN OFF AND BACK ON DID RESET THE NUMBERS. THE PATIENT WAS PLACED ON A HEARTMATE TOUCH AND LOG FILES WERE OBTAINED AND SUBMITTED FOR EVALUATION. THE EVENT LOG CONTAINED CLUSTERS OF PULSATILITY INDEX (PI) EVENTS AS WELL AS ROUTINE POWER SOURCE CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637641 ↗