HeartStart MRx monitor/defib 861464Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00884838006676), received between Aug 10, 2017 and Mar 7, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (5 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Battery Problem; Battery Problem

  PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX DEVICE INDICATING THAT THERE WAS A BATTERY PROBLEM. THE CUSTOMER WAS INFORMED THAT SERVICE COULD NO LONGER BE COMPLETED ON THE UNIT AS THE DEVICE HAD REACHED END OF LIFE (EOL). THE HEARTSTART MRX DEVICE AND ALL ASSOCIATED SERVICE/SUPPORT WAS DISCONTINUED ON 03-FEB-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547596 ↗
• MalfunctionAug 20, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART MRX DEVICE FAILED THE FUNCTIONAL TEST OF THE EXTERNAL PLATES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006934 ↗
• MalfunctionJul 25, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART MRX DEFIBRILLATOR EXHIBITED CO2 CALIBRATION PROBLEMS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831644 ↗
• MalfunctionApr 15, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX DEFIBRILLATOR INDICATING THAT THE DEVICE IS FAILING THE OPERATIONAL CHECK. THE EVENT WAS OUTSIDE OF USE AND THERE WAS NO REPORTED PATIENT NOR USER HARM. AVAILABLE DETAILS INDICATE THAT THE DEVICE IS FAILING THE OPERATIONAL CHECK AS THE CHARGE BUTTON CLEARS EVERYTHING WHEN IT IS PRESSED. PER SOURCE NOTES, NO SERVICE OR TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER DUE TO END OF SUPPORT STATUS OF THE DEVICE. THE CUSTOMER WAS MADE AWARE OF THE END OF LIFE TERMS AND THE EOL NOTICE WAS EMAILED TO THE CUSTOMER. THE HEARTSTART MRX DEVICE AND ALL ASSOCIATED SERVICE/SUPPORT WAS DISCONTINUED ON 03-FEB-2022. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ADDITIONAL INVESTIGATION AS NO REPLACEMENT WILL BE PROVIDED. DEVICE REMAINS AT THE CUSTOMER SITE. BECAUSE THE DEVICE REACHED THE END-OF-LIFE AND END-OF-SUPPORT STATUSES, IT CANNOT BE REPAIRED. THE CAUSE OF THE REPORTED PROBLEM IS UNKNOWN AND CANNOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105734 ↗
• MalfunctionAug 25, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED TO PHILIPS THAT THE ECG CABLE (3 LEADSET, GRABBER, IEC, ICU) IS FAULTY. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME, HOWEVER, NO ADVERSE PATIENT IMPACT OR INJURY WAS REPORTED BY THE CUSTOMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628262 ↗
• MalfunctionAug 25, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED TO PHILIPS THAT THE ECG CABLE IS FAULTY. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME, HOWEVER, NO ADVERSE PATIENT IMPACT OR INJURY WAS REPORTED BY THE CUSTOMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17626910 ↗
• MalfunctionAug 25, 2023Circuit Failure; Power Problem; Circuit Failure; Power Problem

  IT WAS REPORTED TO PHILIPS THAT THE POWERBOARD NEEDS TO BE REPLACED. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME, HOWEVER, NO ADVERSE PATIENT IMPACT OR INJURY WAS REPORTED BY THE CUSTOMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17626034 ↗
• MalfunctionAug 25, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE DEVICE'S AC POWER SUPPLY EMITS A BUZZ. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. THE CUSTOMER EVALUATED THE DEVICE AND RECEIVED REMOTE SUPPORT FROM THE CUSTOMER CARE SOLUTION CENTER, DURING WHICH AN AC POWER SUPPLY WAS ORDERED UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE AC POWER SUPPLY, THE REPLACEMENT FOR WHICH WAS ORDERED. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298324 ↗
• MalfunctionMay 31, 2022No Device Output; No Device Output

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE DOESN'T GIVE OUTPUT WHEN TRYING TO CARDIOVERT. THE REMOTE SERVICE ENGINEER (RSE) CALLED AND SPOKE TO THE CUSTOMER AND EXPLAINED THAT THE MRX DEVICE IS NO LONGER SUPPORT BY PHILIPS AS OF 2/3/22, MADE MENTION THAT IF IN NEED OF A REPLACEMENT MRX, THEY CAN CONTACT A 3RD PARTY VENDOR, WORK THROUGH THEM, AND RECEIVE REIMBURSEMENT FROM PHILIPS. THE CUSTOMER WAS INFORMED THAT PARTS/SERVICE ARE NO LONGER AVAILABLE AS THE DEVICE HAS REACHED END OF SUPPORT. THE CUSTOMER IS AWARE OF THE END OF LIFE TERMS AND THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14546235 ↗
• MalfunctionApr 12, 2022Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE'S BATTERY EXPERIENCED A SHORTAGE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER WAS INFORMED THAT SERVICE COULD NO LONGER BE COMPLETED ON THE UNIT AS THE DEVICE HAD REACHED END OF LIFE (EOL). THE HEARTSTART MRX DEVICE AND ALL ASSOCIATED SERVICE/SUPPORT WAS DISCONTINUED ON 03-FEB-2022. AS TROUBLESHOOTING WAS NOT COMPLETED FOR THE DEVICE, THE REPORTED ISSUE COULD NOT BE VERIFIED AND A CAUSE COULD NOT BE ESTABLISHED. THE CUSTOMER WAS AWARE OF THE END OF LIFE TERMS AND THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14085233 ↗
• MalfunctionApr 10, 2022Energy Output Problem; Energy Output Problem

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE CAPACITOR WAS DEFECTIVE AND REQUIRED REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER REQUESTED ASSISTANCE FROM A PHILIPS CUSTOMER SERVICE REPRESENTATIVE. THE CUSTOMER EXPLAINED THAT THE CAPACITOR FOR THEIR DEVICE NEEDED TO BE REPLACED. THE CUSTOMER WAS INFORMED THAT SERVICE COULD NO LONGER BE COMPLETED ON THE UNIT AS THE DEVICE HAD REACHED END OF LIFE (EOL). THE HEARTSTART MRX DEVICE AND ALL ASSOCIATED SERVICE/SUPPORT WAS DISCONTINUED ON (B)(6) 2022. BASED ON THE AVAILABLE INFORMATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE CAPACITOR. THE CUSTOMER WAS INFORMED THAT PARTS/SERVICE ARE NO LONGER AVAILABLE AS THE DEVICE HAS REACHED END OF SUPPORT. THE CUSTOMER IS AWARE OF THE END OF LIFE TERMS AND THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14069314 ↗
• MalfunctionApr 8, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE CO2 MODULE WAS DEFECTIVE AND REQUIRED REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER REQUESTED ASSISTANCE FROM A PHILIPS CUSTOMER SERVICE REPRESENTATIVE. THE CUSTOMER EXPLAINED THAT THE CO2 MODULE FOR THEIR DEVICE NEEDED TO BE REPLACED. THE CUSTOMER WAS INFORMED THAT SERVICE COULD NO LONGER BE COMPLETED ON THE UNIT AS THE DEVICE HAD REACHED END OF LIFE (EOL). THE HEARTSTART MRX DEVICE AND ALL ASSOCIATED SERVICE/SUPPORT WAS DISCONTINUED ON (B)(6) 2022. BASED ON THE AVAILABLE INFORMATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE CO2 MODULE. THE CUSTOMER WAS INFORMED THAT PARTS/SERVICE ARE NO LONGER AVAILABLE AS THE DEVICE HAS REACHED END OF SUPPORT. THE CUSTOMER IS AWARE OF THE END OF LIFE TERMS AND THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14060173 ↗
• MalfunctionMar 30, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE DEVICE IS FAILING THE AUTO TEST. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. THE CUSTOMER WAS INFORMED THAT SERVICE COULD NO LONGER BE COMPLETED ON THE UNIT AS THE DEVICE HAD REACHED END OF LIFE (EOL). THE HEARTSTART MRX DEVICE AND ALL ASSOCIATED SERVICE/SUPPORT WAS DISCONTINUED ON (B)(6) 2022. AS TROUBLESHOOTING WAS NOT COMPLETED FOR THE DEVICE, THE REPORTED ISSUE COULD NOT BE VERIFIED AND A CAUSE COULD NOT BE ESTABLISHED. THE CUSTOMER WAS AWARE OF THE END OF LIFE TERMS AND THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953246 ↗
• MalfunctionMar 9, 2022Circuit Failure; Circuit Failure

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE CO2 DID NOT PASS OPERATIONAL CHECK TESTING. THERE WAS NO PATIENT INVOLVEMENT. THE BENCH TECHNICIAN EVALUATED THE DEVICE AND CONFIRMED THE CO2 WAS NOT WORKING. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THE CO2 MODULE AND THERAPY PCA REQUIRES REPLACEMENT. IT WAS REPLACED. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT AS MULTIPLE PARTS WERE REQUIRED FOR REPLACEMENT. THE DEVICE MEETS THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS RETURNED TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712240 ↗
• MalfunctionMar 9, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE BENCH TECHNICIAN WHILE WORKING ON THE DEVICE FOUND PROCESSOR PCA OUTPUT ECG OUT CONNECTOR DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THE BENCH TECHNICIAN WHILE WORKING ON THE DEVICE FOUND PROCESSOR PCA OUTPUT ECG OUT CONNECTOR DAMAGED. THE PROCESSOR PCA NEEDS T BE REPLACED. THE BENCH TECHNICIAN WHILE WORKING ON THE DEVICE FOUND PROCESSOR PCA OUTPUT ECG OUT CONNECTOR DAMAGED. THE PROCESSOR PCA WAS REPLACED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712229 ↗
• MalfunctionMar 9, 2022Failure to Charge; Failure to Charge

  THE BENCH TECHNICIAN WHILE WORKING ON THE DEVICE FOUND LOW OUTPUT POWER BY THE HIGH VOLTAGE CAPACITOR. THERE WAS NO PATIENT INVOLVEMENT. THE BENCH TECHNICIAN WHILE WORKING ON THE DEVICE FOUND LOW OUTPUT POWER BY THE HIGH VOLTAGE CAPACITOR. THE DEVICE NEEDS A HIGH VOLTAGE CAPACITOR. UPON SERVICING THE DEVICE IT WAS FOUND THAT THE HIGH VOLTAGE CAPACITOR WAS MALFUNCTIONING. THEREFORE, THE HIGH VOLTAGE CAPACITOR WAS REPLACED WHICH RESOLVED THE PROBLEM. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711198 ↗
• MalfunctionFeb 21, 2022Electrical /Electronic Property Problem; Failure of Device to Self-Test; Electrical /Electronic Property Problem; Failure of Device to Self-Test

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE EXPERIENCED A CHARGE BUTTON FAILURE, AND SHOWED AN ERROR MESSAGE THAT SERVICE IS REQUIRED. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER WAS PROVIDED REMOTE SUPPORT FROM AN AUTHORIZED REMOTE SERVICE ENGINEER (RSE). ERROR MESSAGING SUGGEST A SHOCK MAY NOT BE ABLE TO BE PERFORMED. THE RSE WAS UNABLE TO REPLICATE THE REPORTED FAILURE THROUGH REMOTE SERVICE. CURRENT OPERATION CHECKS PASSED WITH NO ERRORS. STATUS LOGS POINT TO THE FAILED OP CHECK BEING AN ISOLATED INCIDENT (ONLY ONE OCCURRENCE). SINCE THE USERS ROUTINELY PERFORM THIS OPERATIONAL CHECK ON SEVERAL MRX UNITS IN THE AM EVERYDAY, ITS POSSIBLE THAT THEY RAN THIS PARTICULAR CHECK AND WALKED AWAY WITHOUT PRESSING THE CHARGE BUTTON. THE DEVICE CAN FINISH ITS OPERATIONAL CHECK WITHOUT THE PRESS OF THE BUTTON BUT IT REPORTS THIS AS A MAJOR FAILURE AND YIELDS THE "DEVICE NEEDS SERVICE" MESSAGE IN NORMAL MODE. PHILIPS IS UNABLE TO RULE OUT THAT A MALFUNCTION DID NOT OCCUR. AS THE ISSUE COULD NOT BE REPLICATED DURING EVALUATION, A DEFINITIVE CAUSE FOR THE ALLEGED FAILURE COULD NOT BE DETERMINED. COMPETED A CHARGE BUTTON TEST AND PASSED A CURRENT OPERATIONAL CHECK. ERROR MESSAGE WENT AWAY AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573510 ↗
• MalfunctionDec 6, 2021Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED TO PHILIPS THAT THE BLOOD PRESSURE AND CO2 WILL NOT HOLD CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933290 ↗
• MalfunctionNov 8, 2021Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE EXPERIENCED A CO2 CALIBRATION FAILURE. THE CUSTOMER REQUESTED ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE CUSTOMER EXPLAINED THAT THEIR UNIT WAS NOT SHOWING A CO2 VALUE AND SUBSEQUENTLY FAILING OPERATIONAL TESTING. BASED ON THE NOTED ISSUE, THE RSE ADVISED THE CUSTOMER TO SWAP OUT THE CO2 CABLE IN AN ATTEMPT TO TROUBLESHOOT THE ISSUE. SHOULD THE ISSUE REMAIN, THE CUSTOMER WAS THEN INSTRUCTED TO REPLACE THE ETCO2 MODULE. BASED ON THE CONCLUSION OF THE INVESTIGATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE CO2 CABLE. THE CUSTOMER FOLLOWED THE INSTRUCTION PROVIDED BY THE RSE AND VERIFIED THAT SWAPPING OUT THE CO2 CABLE RESOLVED THE REPORTED FAILURE. THE DEVICE REMAINS AT THE CUSTOMER SITE. THERE IS NO INDICATION OF A SYSTEMIC PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771830 ↗
• MalfunctionOct 26, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED TO PHILIPS THAT THE CO2 MODULE WAS NOT WORKING. THE CUSTOMER REQUESTED ASSISTANCE FROM A PHILIPS REPRESENTATIVE. THE CUSTOMER EXPLAINED THAT THE CO2 MODULE FOR THEIR DEVICE WAS FAULTY AND NEEDED TO BE REPLACED. THE SERVICE ORDER WAS INITIATED AS A MEANS FOR THE CUSTOMER TO OBTAIN A QUOTE FOR THE COST OF REPAIR AT THE BENCH AND AN EVALUATION OF THE DEVICE WAS NOT REQUESTED AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE CO2 MODULE. THE CUSTOMER WAS PROVIDED A QUOTE FOR THE COST OF THE REPAIR AND WILL CREATE A NEW SERVICE ORDER IF THEY WISH TO RESOLVE THE REPORTED ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER ASSISTANCE WAS REQUIRED OR REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701067 ↗
• MalfunctionAug 31, 2021Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE DEVICE RESPONDED WITH AN ERROR THAT AT STARTUP DEFIBRILLATOR PADS FAILED. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12399471 ↗
• MalfunctionAug 11, 2021Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILED TO PERFORM CO2 CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311000 ↗
• MalfunctionAug 11, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY NEEDS REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307281 ↗
• MalfunctionJul 31, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO PHILIPS THAT THE PADDLES DO NOT WORK, NOT RECOGNIZING THE PADS. THE CUSTOMER WORKED WITH THE TECHNICAL SUPPORT REPRESENTATIVE. THE CUSTOMER'S UPDATE FINDS THE ISSUE RESOLVED ITSELF. THE CUSTOMER'S UPDATE FINDS THE ISSUE RESOLVED ITSELF. THE CUSTOMER WISHES TO CANCEL THE CASE. PHILIPS CANNOT RULE OUT A MALFUNCTION AT THE TIME IT WAS REPORTED, BUT NO PROBLEM COULD BE REPRODUCED AND NO REPAIR WAS WARRANTED. THERE IS NO INDICATION OF A SYSTEMIC PROBLEM; NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257034 ↗
• MalfunctionAug 10, 2017Moisture Damage

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE BECAME WET DURING OPERATION AND "MONITOR NOT FUNCTIONING". THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6784831 ↗