PHILIPS HeartStart OnSite M5066ARecalls & reported problems
Philips Electronics North America Corporation · HeartStart Defibrillator, HS1 · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Philips HeartStart OnSite defibrillator has 790 FDA reports, with 784 malfunctions, 6 deaths reported and no injuries. Many reports describe the device failing its self-test, shutting down unexpectedly or not powering on, and several link these problems to battery trouble. There are no recalls naming this device. Reports fell from 13 in the previous 12 months to 0 in the most recent 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
- 790
- Deaths reported
- 6
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 790 adverse event reports that list this exact device (DI 00884838049123), received between Nov 15, 2016 and Jul 7, 2025 — classified as 6 deaths, 784 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (425 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.
Reports received per month
Most reported problems
Device problems
- Failure of Device to Self-Test425
- Device Operates Differently Than Expected197
- Incorrect, Inadequate or Imprecise Result or Readings66
- Failure to Power Up21
- Break8
- Defective Device8
- Inaudible or Unclear Audible Prompt/Feedback8
- Premature Discharge of Battery8
Patient problems
- No Known Impact Or Consequence To Patient422
- No Clinical Signs, Symptoms or Conditions301
- Insufficient Information35
- No Patient Involvement16
- No Information12
- Cardiac Arrest4
- Death3
Recent adverse event reports
The 25 most recent of 790 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE HAS FAILED A SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22421163 ↗MalfunctionApr 30, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937306 ↗MalfunctionApr 4, 2025Unexpected Shutdown; Unexpected Shutdown
IT HAS BEEN REPORTED THAT THE DEVICE UNEXPECTEDLY SHUT DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21770415 ↗MalfunctionApr 2, 2025Failure to Run on Battery; Failure to Run on Battery
IT HAS BEEN REPORTED THAT THE BATTERY WOULD NOT POWER ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752972 ↗MalfunctionApr 2, 2025Failure to Run on Battery; Failure to Run on Battery
IT HAS BEEN REPORTED THAT THE DEVICE BATTERY IS LOW AND WILL NOT COMPLETE A SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752971 ↗MalfunctionApr 1, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT HAS BEEN REPORTED THAT THE BATTERY WAS PREMATURELY DRAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749261 ↗MalfunctionMar 21, 2025Failure to Power Up; Failure to Power Up
IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21666454 ↗MalfunctionMar 14, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21609605 ↗MalfunctionMar 4, 2025Break; Break
IT HAS BEEN REPORTED THAT THE PLASTIC PINS HOLDING PADS IN PLACE WERE BROKEN OFF, PREVENTING PADS FROM SITTING IN DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514090 ↗MalfunctionFeb 19, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411703 ↗MalfunctionJan 21, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200149 ↗MalfunctionJan 17, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE HAS FAILED A SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179490 ↗MalfunctionNov 22, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20758047 ↗MalfunctionOct 24, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521657 ↗MalfunctionOct 8, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396579 ↗MalfunctionSep 5, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20147249 ↗MalfunctionAug 23, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20057892 ↗MalfunctionAug 13, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19970023 ↗MalfunctionJun 27, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19624116 ↗MalfunctionJun 27, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19621951 ↗MalfunctionJun 26, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19619684 ↗MalfunctionJun 24, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19596259 ↗MalfunctionJun 23, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19591766 ↗MalfunctionMay 22, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19376789 ↗MalfunctionApr 18, 2024Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133326 ↗
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
- 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
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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