THORATEC® HEARTMATE®, SYSTEM MONITOR 1286A-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 00813024010852), received between Nov 20, 2018 and Jan 30, 2026 — classified as 2 injuries, 183 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (128 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 185 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT ON (B)(6) 2026 WHILE IN THE INTENSIVE CARE UNIT (ICU) AND USING THE SYSTEM MONITOR, THE DISPLAY DISAPPEARED IN TWO PLACES AND THEN BLACKED OUT AND RESTARTED. THERE WAS NO PROBLEM WITH THE DISPLAY AFTER RESTARTING. NO HEALTH HAZARD OCCURRED TO THE PATIENT. LOG FILE ANALYSIS WAS REQUESTED OUT OF CAUTION FOR THE PATIENT WHO WAS BEING CARED FOR USING THE SYSTEM MONITOR, AND THE LOG FILES CAPTURED NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE PATIENT'S EQUIPMENT WAS OPERATING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223996 ↗
• MalfunctionJul 18, 2025Pumping Stopped; Improper or Incorrect Procedure or Method; Pumping Stopped; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED DUE TO PUMP OFF EPISODE. DURING OPERATION, THROMBECTOMY FROM LEFT VENTRICULAR CAVITY WAS DONE, LEFT ATRIAL APPENDAGE (LAA) WAS CLOSED. IN OPERATING ROOM, SYSTEM CONTROLLER WAS PROGRAMMED AS USUAL; BACKUP BATTERY WAS INSTALLED. AFTER TRANSFER TO INTENSIVE CARE UNIT (ICU), APPROXIMATELY 30 MIN LATER, PUMP OFF ALARM SHORTLY APPEARED WITH DROP OF ARTERIAL PRESSURE. IMPLANT TEAM CAME TO THE ICU, AND CHECKED ON PATIENT CONDITION, PUMP, SYSTEM CONTROLLER AND POWER CONNECTIONS. NO TECHNICAL ISSUES WERE NOTED. THE PATIENT REMAINED STABLE. THE LOG FILE CAPTURED ON (B)(6) 2025 AT 13:31:40, INTENTIONAL PUMP STOP MESSAGES (F69). IT APPEARED TO HAVE OCCURRED BY THE SYSTEM MONITOR PUMP STOP COMMAND BEING ACTIVATED. THE PUMP WAS STOPPED FOR ABOUT 2 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542410 ↗
• MalfunctionJul 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AND THE SYSTEM MONITOR DISPLAYED THE PUMP SPEED AT 21,536 REVOLUTIONS PER MINUTE (RPM). THE SYSTEM CONTROLLER DISPLAYED THE SPEED AT 5,200 RPM. THE SPEED WAS ABLE TO BE CHANGED IN THE SETTING WINDOW OF THE SYSTEM MONITOR, BUT EVEN AFTER THE CHANGE THE SYSTEM MONITOR STILL DISPLAYED THE SPEED AT 21,536 RPM. AFTER LOG FILES WERE DOWNLOADED, THE TOP TAB OF THE SCREEN STOPPED FUNCTIONING, AND THE CLINICAL TAB WAS DISPLAYED IN THE BOTTOM LEFT. THE ISSUE RESOLVED WHEN THE SYSTEM MONITOR WAS RESTARTED. NO PATIENT ADVERSE EVENT OCCURRED DUE TO THIS EVENT. LOG FILE REVIEW SHOWED NO UNUSUAL EVENTS IN THE EVENT LOG FILE HISTORY. THE MECHANICAL CIRCULATORY SUPPORT EQUIPMENT APPEARED TO BE OPERATING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531304 ↗
• MalfunctionJun 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PATIENT WAS ASYMPTOMATIC. LOG FILES WERE REVIEWED, AND THE EVENT LOG FILE CAPTURED AN INTENTIONAL PUMP STOP ON (B)(6) 2025 AT 14:32:03 CAUSING THE PUMP TO STOP/ THE PUMP RESUMED NORMAL OPERATION AT 14:32:06. THE LOG FILE ALSO CAPTURED INTERMITTENT LOW FLOW ALARMS AND FEW MOMENTARY LOW FLOW ESTIMATES WITH THE CALCULATED PULSATILITY INDEX (PI) ELEVATED STARTING FROM (B)(6) 2025 FROM 21:24 TO 21:48. THERE WERE NO UNUSUAL ROTOR FAULTS, PUMP TEMPERATURE, OR ANY OTHER ABNORMAL PUMP FAULTS WERE SEEN IN THE EVENT LOG. THERE DID NOT APPEAR TO BE ANY TYPE OF EXTERNAL MECHANICAL CIRCULATORY SUPPORT EQUIPMENT ISSUES CAUSING THESE EVENTS. OTHERWISE, THERE WERE NO OTHER NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286007 ↗
• MalfunctionApr 28, 2025Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT ON (B)(6) 2025 TWO INSTANCES OF NO EXTERNAL POWER WERE RECORDED, AND ON (B)(6) 2025, A LOW FLOW ALARM AND A PUMP OFF WERE RECORDED. THE PATIENT WAS ASYMPTOMATIC. LOG DISPLAYED LOW FLOW / LVAD OFF / (F69) INTENTIONAL PUMP STOP EVENTS ON (B)(6) 2025 AT ~8:26 AM WHERE IT APPEARED THE INTENTIONAL PUMP STOP COMMAND WAS MOMENTARILY ENABLED AT THE SYSTEM MONITOR. THE PUMP WAS OFF FOR ~1-2 SECONDS. THE LOG FILES DID NOT RECORD ANY NO EXTERNAL POWER ALARMS. 90 PULSATILITY (PI) EVENTS WERE CAPTURED IN THE EVENT LOG. THERE WERE NO OTHER UNUSUAL EVENTS SEEN WITHIN THE LOG FILES. IT WAS UNKNOWN WHY THE PUMP STOP COMMAND WAS INITIATED. THE CAUSE OF THE NO EXTERNAL POWER ALARMS ALSO REMAINED UNKNOWN. NO EQUIPMENT WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919009 ↗
• MalfunctionApr 23, 2025Device Difficult to Setup or Prepare; Pumping Stopped; Device Difficult to Setup or Prepare; Pumping Stopped

  IT WAS REPORTED THAT PATIENT WITH A SENSITIVE MONITOR SCREEN, SEEMED TO HAVE A PUMP STOP EVENT WHILE IN THE INTENSIVE CARE UNIT DURING DEVICE INTERROGATION. THE SYSTEM MONITOR WOULD BE EXCHANGED, EVEN WHEN DOWNLOADING WHEN PRESSING THE LETTERS FOR PATIENT INITIALS MULTIPLE LETTERS WOULD APPEAR. THE LOG FILE CAPTURED ON (B)(6) 2025, AT 10:02:38 AN INTENTIONAL PUMP STOP, WHICH WAS DUE TO THE KEY ON THE SCREEN BEING ACTIVATED. IN ADDITION, IT WAS NOTED ON (B)(6) 2025 LOW SPEED ADVISORIES DUE TO THE FIXED SPEED BEING SET AT 4800 REVOLUTION PER MINUTE (RPM) AND THE LOW-SPEED LIMIT BEING SET TO 5000 RPMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894860 ↗
• MalfunctionOct 28, 2024Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THE PATIENT'S LOG FILES WERE SUBMITTED FOR ANALYSIS. ON (B)(6) 2024, THE SITE CHECKED THE PATIENT'S HISTORY ON THE SYSTEM MONITOR, WHICH REVEALED THAT THE TOUCH PANEL MALFUNCTIONED. THE SCREEN FOR HEMATOCRIT (HCT) CORRECTION WAS RISING 50% EACH TIME. WHEN THE EVENT LOG TAB WAS TOUCHED, THERE WAS AN ABNORMAL SOUND AND THE SCREEN DID NOT CHANGE. THE SYSTEM MONITOR WAS THEN REBOOTED BY THE FACILITY'S CLINICAL ENGINEER TWICE TO RESTORE NORMAL OPERATION. AFTER THE MONITOR WAS REBOOTED, THEY CHECKED THE HISTORY AND IT APPEARED THAT THERE WERE PUMP OFF AND LOW FLOWS RECORDED. IT WAS UNKNOWN WHETHER THE SYSTEM MONITOR WAS REBOOTED BEFORE USAGE. THE PATIENT HAD NO SYMPTOMS AS A RESULT OF THE PUMP OFF EVENT. FOLLOWING REVIEW OF THE LOG FILES BY TECH SERVICES, IT APPEARED THERE WERE LOW FLOWS WHERE THE LOW FLOW ESTIMATOR DROPPED BELOW 2.5 LPM, WHICH OCCURRED AT TIMES WHEN THE PULSATILITY INDEX (PI) WAS ELEVATED. THE PUMP HAD A REDUCTION IN BLOOD VOLUME AS WELL. THERE DID NOT APPEAR TO BE ANY TYPE OF MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT ISSUES THAT CAUSED THE EVENTS. IT APPEARED THE PUMP STOP COMMAND WAS ENABLED ON (B)(6) 2024 AT ABOUT 1:54 PM, WHICH CAUSED THE TRANSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543132 ↗
• MalfunctionOct 17, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO OTHER REASON. WHILE LYING ON THE HOSPITAL BED WITHOUT ANY SPECIAL ACTIVITIES, THE PATIENT HAD A WARNING MESSAGE THAT STATED "WARNING: LOW SPEED OPERATION¿ THAT WAS ASSOCIATED WITH NO PHYSICAL DISCOMFORT. ACCORDING TO THE DEVICE RECORDS, THE "LOW SPEED OPERATION" WARNING APPEARED ON (B)(6) 2024 AT 0830. THE LOG FILES CONTAINED APPROXIMATELY 9 DAYS OF DATA, AND THE SPEED WAS SET AT 9200 RPM. THE AVERAGE POWER RANGED FROM 1 WATT TO 8 WATTS. THE AVERAGE PULSATILITY INDEX (PI) RANGED FROM 2.9 TO 5.9 AND THE AVERAGE FLOW RANGED FROM 2.4LPM TO 4.8LPM. THE LOG FILES ALSO CONTAINED A LOW-SPEED HAZARD EVENT ON DAY 576 OF SYSTEM CONTROLLER USAGE. THE EVENT APPEARED TO HAVE BEEN ASSOCIATED WITH THE MOTOR STOP COMMAND BEING ACTIVATED. THE PUMP WAS RESTARTED QUICKLY AND CONTINUED TO OPERATE AS INTENDED. AT THE TIME OF THE EVENT, THE PATIENT WAS ON A SYSTEM MONITOR AND PER THE HOSPITAL NURSE, NO ONE WAS OPERATING THE SCREEN. IT WAS NOTED THAT AS THE EVENT DID NOT RECUR DURING FOLLOW-UP, THE DOCTOR DID NOT BELIEVE THERE WAS A NEED TO EXCHANGE ANY PRODUCT AND WAS TO CONTINUE TO MAINTAIN FOLLOW UP WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473106 ↗
• MalfunctionAug 11, 2024Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT THE SYSTEM MONITOR AT THE HOSPITAL WAS CHECKED BECAUSE IT WAS SCHEDULED FOR USE, BUT THE TOUCH OPERATION WAS NOT RECOGNIZED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ALARMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958252 ↗
• MalfunctionJul 29, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS COMMUNICATED ON 15AUG2024 THAT THE ISSUE WAS RESOLVED, BUT THE SITE WAS UNSURE IF THE ISSUE HAD RECURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851718 ↗
• MalfunctionJul 24, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT FOLLOWING THE PATIENT'S DEATH, THE SURGEON TRIED TO TURN OFF THE PUMP AND THE POWER RESTARTED ITSELF; IT WAS NOTED THAT A SYSTEM MONITOR WAS IN USE. THEY EVENTUALLY DISCONNECTED THE DRIVELINE; IT WAS NOTED THAT 2 POWER OFF ATTEMPTS WOULD BE SEEN BEFORE THE DRIVELINE WAS DISCONNECTED. LOG FILES WERE SUBMITTED FOR REVIEW. THE EVENT LOG FILE CONTAINED ALARMS ASSOCIATED WITH THE REPORTED INTENTIONAL PUMP STOP COMMANDS AS WELL AS THE DRIVELINE DISCONNECT ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820717 ↗
• MalfunctionJul 18, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD BEEN GETTING A STRANGE MESSAGE POP UP, "NO RECORDS OBTAINED", WHEN ATTEMPTING TO VIEW THE PATIENT'S HISTORY. LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILE FOR THE PATIENT CONTAINED PERSISTENT LOW SPEED ADVISORY FAULTS. THESE FAULTS APPEARED TO HAVE BEEN THE RESULT OF THE SET SPEED BEING SET BELOW THE LOW-SPEED LIMIT. THESE ALARMS APPEARED TO HAVE RESOLVED ONCE THE LOW-SPEED LIMIT AND SET SPEEDS WERE ADJUSTED. THESE FAULTS ALSO APPEARED TO HAVE CONSUMED THE SYSTEM CONTROLLER MEMORY LIMITING THE DISPLAYABLE DATA ON THE MONITOR WHICH MAY HAVE CAUSED THE ERROR. THERE WERE NO OTHER USUAL ALARM OR EVENTS RECORDED. THE PATIENT CABLE AND THE SYSTEM MONITOR WERE TO BE CHANGED TO SEE IF THE ISSUE COULD BE FIXED. THERE WAS NO DOCUMENTATION ABOUT THE CAUSE OF THE MESSAGE OR TROUBLESHOOTING THAT WAS PERFORMED. THE PATIENT WAS INPATIENT AND PENDING DISCHARGE TO INPATIENT REHABILITATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779788 ↗
• MalfunctionJul 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT SYSTEM MONITOR SHOWED THE EMERGENCY BACKUP BATTERY (EBB) IN THE PRIMARY SYSTEM CONTROLLER NEEDED TO BE REPLACED AS IT WAS EXPIRING. HOWEVER, WHEN LOOKING AT THE BATTERY DATA IT STATED THE BATTERY EXPIRED IN 33 MONTHS. THE EBB WAS RESEATED, AND SELF-TEST WAS DONE. THE MONITOR WAS STILL SHOWING THE EBB EXPIRING. LOG FILES CAPTURED BOTH OF THE TIMES THE EBB WAS RESEATED. SINCE THE MONITOR WAS USED WAS THE OLD ONE, IT WAS RECOMMENDED TO TURN IT OFF AND WAIT ABOUT 15 SECONDS AND LET THE CAPACITORS DISCHARGE. THE MONITOR WAS RESTARTED AND THAT RESOLVED THE ISSUE. NO EQUIPMENT WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667506 ↗
• MalfunctionJul 1, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S EMERGENCY BACKUP BATTERY (EBB) WAS REPLACED EARLIER IN THE DAY DUE TO UPCOMING EXPIRATION. THERE WERE NO ALARMS FOLLOWING THE REPLACEMENT. LATER IN THE DAY, THE PATIENT HAD LEFT VENTRICULAR ASSIST DEVICE (LVAD) OFF ALARMS WITH NO GREEN CIRCLE ILLUMINATED ON THE SYSTEM CONTROLLER WHILE ON POWER MODULE. THE SYSTEM MONITOR WAS ALSO REPORTED TO BE OFF WHEN THE TEAM ENTERED THE ROOM. THE PATIENT WAS SWITCHED TO BATTERIES, BUT THE POWER DID NOT RETURN TO THE SYSTEM. THE CONTROLLER WAS THEN EXCHANGED, AND THE PATIENT WAS CONNECTED TO NEW POWER MODULE WHICH RETURNED POWER TO THE SYSTEM. THE POWER MODULE ALSO HAD A FAINTLY YELLOW LIT POWER MODULE BACKUP BATTERY INDICATOR. IT WAS UNKNOWN IF THE PUMP STOPPED AT ANY TIME WHEN THE SYSTEM WAS OUT OF POWER. LOG FILES WERE TO BE SENT FROM BOTH CONTROLLERS AND THE POWER MODULE WAS TO BE RETURNED FOR FURTHER INVESTIGATION. THE PATIENT WAS ASYMPTOMATIC DURING THE LVAD OFF ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645910 ↗
• MalfunctionJun 24, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION REPORTED THAT THE EXCHANGE OF THE SYSTEM CONTROLLER RESOLVED THE ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19600217 ↗
• MalfunctionJun 17, 2024Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  THE PATIENT WAS NOT CONNECTED TO THE SYSTEM MONITOR AT THE TIME OF THE EVENT. THE POWER MODULE PATIENT CABLE WAS EXCHANGED, AND NO FURTHER ISSUES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552211 ↗
• MalfunctionJun 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR WAS SHOWING INCORRECT NUMBERS WHILE CONNECTED TO THE PATIENT. THE SYSTEM MONITOR ALSO FROZE. THE SYSTEM MONITOR WAS TURNED OFF THEN BACK ON. THE ISSUE RESOLVED AFTER RESTARTING THE SYSTEM MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492845 ↗
• MalfunctionJun 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR HAD JUMBLED ERRONEOUS ERROR MESSAGE INDICATED THAT IT WAS ACTIVE FOR ZERO MINUTES. THE PATIENT WAS STABLE, NO ALARMS WERE SOUNDED, PUMP OPERATING AS INTENDED. THE TEAM TURNED THE SYSTEM MONITOR OFF, THEN BACK ON AGAIN. THE MESSAGE WAS CLEARED. THERE WAS NOT AN ACTIVE ALARM TONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492737 ↗
• MalfunctionJun 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM MONITOR SHOWED A PULSATILITY INDEX OF ZERO. THE PATIENT WAS STABLE, ALL OF THE PARAMETERS ON THE MONITOR APPEARED TO BE NORMAL AND WITHIN NORMAL LIMITS. THE EQUIPMENT AND IT¿S PERIPHERALS OPERATED AS INTENDED AND AS DESIGNED OTHERWISE. THE PATIENT WAS PLACED ON BATTERY SUPPORT HIM THEN THE SYSTEM MONITOR WAS SHUT DOWN AND RE-POWERED ON. AFTER THIS WAS COMPLETED, THE ISSUE WAS RESOLVED IN THAT THE PATIENT HAD A READABLE PULSATILITY INDEX. THE EQUIPMENT NOW IS OPERATING AS INTENDED AND THE PATIENT IS STABLE AT THIS TIME. THERE WERE NO ALARMS FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491497 ↗
• MalfunctionJun 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SETTINGS ON THE SYSTEM MONITOR WOULD NOT WORK. THE SYSTEM MONITOR NEEDED TO BE RECALIBRATED. THIS ISSUE OCCURRED DURING A CLASS, THE SYSTEM MONITOR WAS NOT HOOKED UP TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491427 ↗
• MalfunctionJun 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE NUMBERS WERE NOT BEING DISPLAYED PROPERLY ON THE SYSTEM MONITOR. IT WAS INSTRUCTED TO POWER OFF THE MONITOR THEN POWER ON TO CLEAR THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490171 ↗
• MalfunctionJun 7, 2024Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT SYSTEM MONITOR SCREEN WAS DIM AFTER IT WAS REPAIRED BY THE MANUFACTURER FOR A RAM ERROR. THE SYSTEM MONITOR FAILED THE HOSPITAL'S INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489670 ↗
• MalfunctionJun 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING PUMP PREPARATION, THE SYSTEM MONITOR SCREEN DID NOT RECOGNIZE TOUCH TO INITIATE PUMP PREP. THE SYSTEM MONITOR WAS TURNED OFF AND BACK ON BUT THE ISSUE DID NOT RESOLVE. WHEN THE BUTTONS WERE PRESSED FIRMLY THE SYSTEM MONITOR STATED "COMMAND NOT SENT." SYSTEM MONITOR WAS EXCHANGED AND PUMP PREPARATION WAS COMPLETED WITH THE NEW SYSTEM MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489496 ↗
• MalfunctionJun 7, 2024Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT THE SYSTEM MONITOR SCREEN HAD LINES GOING THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488504 ↗
• MalfunctionJun 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SYSTEM MONITOR SETTINGS TAB BUTTON STOPPED WORKING WHEN THE SURGEON TRIED TO TURN UP THE SPEED AND COME OFF BYPASS DURING A HEARTMATE II IMPLANT PROCEDURE. THE SYSTEM MONITOR SCREEN WAS CLEANED, THE SYSTEM MONITOR WAS TURNED OFF AND BACK ON, AND UNPLUGGED AND PLUGGED BACK IN. THE CLINICAL, ADMIN, AND HISTORY TABS WORKED FINE, BUT THE SETTINGS TAB DID NOT FUNCTION. THE SYSTEM MONITOR APPEARED TO NEED TOUCHSCREEN CALIBRATION. ANOTHER SYSTEM MONITOR WAS BROUGHT INTO THE OPERATING ROOM TO BE USED. THE ORIGINAL SYSTEM MONITOR WAS BROUGHT TO THE HOSPITAL'S BIOMED DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488184 ↗