NA 861288Recalls & reported problems
Philips Medical Systems Hsg · HeartStart MRx monitor/defib · Class 3
Quick summary
This Philips HeartStart MRx is a non-wearable external defibrillator and monitor. Reports often describe self-test failures, battery problems and electrical faults, and some mention the device not powering up. The device appears in 5,008 reports, including 21 deaths and 65 injuries. No recalls name this device. Reports dropped to 99 in the last 12 months from 206 before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 5,015
- Deaths reported
- 21
- Injuries reported
- 65
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,015 adverse event reports that list this exact device (DI 00884838000018), received between Apr 21, 2015 and Sep 30, 2026 — classified as 21 deaths, 65 injuries, 4,929 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (1,067 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure of Device to Self-Test1,067
- Battery Problem536
- Electrical /Electronic Property Problem440
- Defibrillation/Stimulation Problem290
- Power Problem256
- Failure to Power Up216
- Failure to Charge192
- Device Operates Differently Than Expected165
Patient problems
- No Clinical Signs, Symptoms or Conditions3,835
- No Patient Involvement661
- No Known Impact Or Consequence To Patient395
- No Consequences Or Impact To Patient44
- Insufficient Information32
- Unspecified Heart Problem29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available17
- Cardiac Arrest14
Recent adverse event reports
The 25 most recent of 5,015 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure of Device to Self-Test
This report is based on information provided by Philips authorized service provider (ASP) with an investigation documented by Philips Complaint Handling. Philips received a complaint on the HeartStart MRx monitor/defib indicating that the functional test failed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941993 ↗MalfunctionSep 29, 2026Failure to Deliver Shock/Stimulation
Philips received a complaint on the Defibrillator indicating that the device had discharge fault in bootup self test. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927544 ↗MalfunctionSep 29, 2026Failure of Device to Self-Test
Philips received a complaint on the Defibrillator indicating that the device therapy delivery rest failed. There is no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927289 ↗MalfunctionSep 22, 2026Intermittent Continuity
Philips received a complaint on the Defibrillator indicating that the device paddle unrecognized. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849879 ↗MalfunctionSep 21, 2026Insufficient Device Problem Information
Philips received a complaint on the Defibrillator indicating that the device had unspecified alarm. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835969 ↗MalfunctionSep 14, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747963 ↗MalfunctionSep 9, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698186 ↗MalfunctionSep 4, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50609686 ↗MalfunctionAug 31, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518993 ↗MalfunctionAug 31, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518639 ↗MalfunctionAug 31, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515026 ↗MalfunctionAug 21, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50369205 ↗MalfunctionAug 17, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50276748 ↗MalfunctionAug 14, 2026Electrical /Electronic Property Problem
Philips received a complaint on the Defibrillator indicating that the paddle was flashing red light. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247546 ↗MalfunctionAug 10, 2026Defibrillation/Stimulation Problem
Philips received a complaint on the HeartStart MRx monitor/defibrillator indicating the device can only be discharged by pressing the button, but not via the pads causing failure of the functional verification test. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192019 ↗MalfunctionAug 7, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174890 ↗MalfunctionAug 7, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174889 ↗MalfunctionAug 7, 2026Defibrillation/Stimulation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174888 ↗MalfunctionAug 7, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174887 ↗MalfunctionAug 7, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174886 ↗MalfunctionAug 7, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174379 ↗MalfunctionAug 7, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173306 ↗MalfunctionJul 21, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25894572 ↗MalfunctionJul 9, 2026Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX INDICATING THAT THE HANDS-FREE PAD CABLE WAS FAULTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25760908 ↗MalfunctionJun 23, 2026Battery Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX DEFIBRILLATOR/MONITOR INDICATING THAT THE BATTERY IS SHOWING SIGNS OF WEAKNESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25593815 ↗
Other Automated External Defibrillators (Non-Wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861289Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)7 deaths3,385 reports
- R SERIES 30001005201310012Zoll Medical Corporation · Automated external defibrillators (non-wearable)10 deaths1,720 reports
- PHILIPS HeartStart FRxPhilips Electronics North America Corporation · Automated external defibrillators (non-wearable)26 deaths1,586 reports
- LIFEPAK CR2 99512Physio-Control, Inc. · Automated external defibrillators (non-wearable)8 deaths1,502 reports
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
- AED PLUS 20000000100011010Zoll Medical Corporation · Automated external defibrillators (non-wearable)16 deaths1,072 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.