PHILIPS HeartStart FRxRecalls & reported problems
Philips Electronics North America Corporation · HeartStart FRx Defibrillator · Class 3
Quick summary
This Philips HeartStart FRx is an automated external defibrillator. Its 1,570 reports mostly describe the defibrillator failing its self-test, and some describe failure to power up or run on battery. Some reports involve patients in cardiac arrest. The reports mention 25 deaths and 10 injuries. No recalls name this device.
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
- 1,586
- Deaths reported
- 26
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,586 adverse event reports that list this exact device (DI 00884838080768), received between Nov 29, 2016 and Sep 30, 2026 — classified as 26 deaths, 10 injuries, 1,550 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (1,125 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-Test1,125
- Failure to Power Up137
- Incorrect, Inadequate or Imprecise Result or Readings63
- Device Operates Differently Than Expected40
- No Audible Prompt/Feedback30
- Failure to Run on Battery28
- Inaudible or Unclear Audible Prompt/Feedback22
- Premature Discharge of Battery22
Patient problems
- No Clinical Signs, Symptoms or Conditions1,366
- No Known Impact Or Consequence To Patient135
- Insufficient Information45
- Cardiac Arrest28
- Unspecified Heart Problem7
- Death6
- No Patient Involvement5
- No Information4
Recent adverse event reports
The 25 most recent of 1,586 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955128 ↗MalfunctionSep 30, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952969 ↗MalfunctionSep 29, 2026Failure 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 50927859 ↗DeathSep 28, 2026Failure of Device to Self-Test
Philips received a complaint on the HeartStart FRx indicating that a patient was found unresponsive while sleeping and they were unable to locate a pulse. When the pads were applied, the device began chirping and a second device had to be obtained. The outcome was a patient death.
Patient problems: Insufficient Information
MAUDE report 50926006 ↗MalfunctionSep 25, 2026Failure 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 50898526 ↗MalfunctionSep 25, 2026Failure to Power Up
It has been reported the device will not power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896792 ↗MalfunctionSep 25, 2026Failure 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 50893326 ↗MalfunctionSep 24, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890061 ↗MalfunctionSep 22, 2026Failure of Device to Self-Test
AED not in clinical use. AED giving pads error for multiple sets of pads when pads function properly in other devices. Replacing AED under warranty.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852831 ↗MalfunctionSep 16, 2026No Visual Prompts/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794083 ↗MalfunctionSep 13, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747530 ↗MalfunctionSep 13, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747529 ↗MalfunctionSep 9, 2026Failure 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 50684447 ↗MalfunctionSep 9, 2026Premature Discharge of Battery; Failure to Power Up
It has been reported that the device may be prematurely draining batteries. The device will not power up.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50682927 ↗MalfunctionSep 4, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50620782 ↗MalfunctionSep 3, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594950 ↗MalfunctionSep 3, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594948 ↗MalfunctionSep 3, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589370 ↗MalfunctionSep 3, 2026Failure 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 50578765 ↗MalfunctionSep 1, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551255 ↗MalfunctionSep 1, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544740 ↗MalfunctionAug 27, 2026Failure 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 50484522 ↗MalfunctionAug 25, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50437097 ↗MalfunctionAug 21, 2026Inaudible or Unclear Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50380850 ↗MalfunctionAug 21, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50378900 ↗
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
- 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.