NA 861289Recalls & reported problems
Philips Medical Systems Hsg · HeartStart MRx ALS monitor · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Philips HeartStart MRx ALS monitor is a defibrillator and heart monitor. Many reports describe the device failing to get readings, failing its self-test, or having battery and power problems. The 3,382 reports include 7 deaths and 28 injuries. No recalls name this device. Reports fell to 25 in the last 12 months from 77 in the previous 12 months.
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
- 3,385
- Deaths reported
- 7
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,385 adverse event reports that list this exact device (DI 00884838006652), received between Nov 18, 2016 and Sep 30, 2026 — classified as 7 deaths, 28 injuries, 3,350 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (494 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
- Unable to Obtain Readings494
- Failure of Device to Self-Test441
- Battery Problem271
- Electrical /Electronic Property Problem212
- Power Problem173
- Incorrect, Inadequate or Imprecise Result or Readings133
- Material Twisted/Bent125
- Naturally Worn111
Patient problems
- No Clinical Signs, Symptoms or Conditions2,556
- No Patient Involvement434
- No Known Impact Or Consequence To Patient303
- Insufficient Information46
- No Consequences Or Impact To Patient34
- Cardiac Arrest22
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Unspecified Heart Problem4
Recent adverse event reports
The 25 most recent of 3,385 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 ALS monitor indicating that the device does not pass the functional test due to that it had defibrillation problems and did not detect the load cable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941715 ↗MalfunctionSep 29, 2026Failure of Device to Self-Test
Philips received a complaint on the Defibrillator indicating that the device did not pass the operational check. There is no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927539 ↗MalfunctionSep 14, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765541 ↗MalfunctionSep 9, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690960 ↗MalfunctionAug 31, 2026Failure to Run on Battery; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518477 ↗MalfunctionAug 25, 2026Failure of Device to Self-Test
Philips received a complaint on the Defibrillator indicating that the system self-test not pass. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50422697 ↗MalfunctionAug 16, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268633 ↗MalfunctionJul 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50048965 ↗MalfunctionJul 27, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015854 ↗MalfunctionMay 13, 2026Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE PADS ARE DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165189 ↗MalfunctionMay 13, 2026Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX DEFIBRILLATOR MONITOR INDICATING THAT A RED X WITH "ECG CABLE FAILED" MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164600 ↗MalfunctionApr 28, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE DEVICE FAILED SELF-TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25021041 ↗MalfunctionApr 28, 2026Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR DEFIBRILLATOR INDICATING THAT THE ETCO2 CALIBRATION EXPIRED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018952 ↗MalfunctionApr 28, 2026Battery Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE BATTERY IS LOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017849 ↗MalfunctionMar 25, 2026Break; Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE PLATE IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690067 ↗MalfunctionFeb 16, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE DEVICE DOES NOT PASS THE FUNCTIONAL TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24349858 ↗MalfunctionFeb 13, 2026Battery Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE BATTERY CONCERN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24331883 ↗MalfunctionFeb 9, 2026Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR DEVICE INDICATING THAT THE DEVICE RESPONDED WITH ERROR, SERVICE REQUIRED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298732 ↗MalfunctionFeb 3, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE SELF-TEST FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246882 ↗MalfunctionFeb 3, 2026Break; Electrical /Electronic Property Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE 3-LEAD ECG TERMINAL CABLE IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245474 ↗MalfunctionFeb 2, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT ON THE DEFIBRILLATOR INDICATING THAT THE DEVICE FAILED ITS POWER ON SELFTEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24231603 ↗MalfunctionJan 30, 2026Failure to Charge
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THAT THE DEVICE FAILED TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24227349 ↗MalfunctionJan 30, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX ALS MONITOR INDICATING THE SELF-TEST FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24226755 ↗MalfunctionJan 8, 2026Failure of Device to Self-Test
PHILIPS RECEIVED A COMPLAINT ON THE DEFIBRILLATOR INDICATING THAT THE DEVICE FAILED THE SELF-TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24000490 ↗MalfunctionDec 26, 2025Battery Problem; Battery Problem
PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART MRX DEFIBRILLATOR INDICATING THAT THE DEVICE NEEDS A BATTERY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23898014 ↗
Other Automated External Defibrillators (Non-Wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861288Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)21 deaths5,015 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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