PHILIPS HeartStart FRxRecalls & reported problems across all models
Philips Electronics North America Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,943
- Deaths reported
- 32
- Injuries reported
- 10
- Recalls
- 0
We found 3 models of PHILIPS HeartStart FRx by Philips Electronics North America Corporation in the FDA's device registry (GUDID). Together they are named in 1,943 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Sep 30, 2026 — classified as 32 deaths, 10 injuries, 1,901 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (1,322 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PHILIPS HeartStart FRx problems
Device problems
- Failure of Device to Self-Test1,322
- Failure to Power Up150
- Incorrect, Inadequate or Imprecise Result or Readings109
- Device Operates Differently Than Expected107
- No Audible Prompt/Feedback31
- Failure to Run on Battery28
- Premature Discharge of Battery28
- Inaudible or Unclear Audible Prompt/Feedback24
Patient problems
- No Clinical Signs, Symptoms or Conditions1,524
- No Known Impact Or Consequence To Patient306
- Insufficient Information60
- Cardiac Arrest28
- Death12
- No Information8
- No Patient Involvement8
- Unspecified Heart Problem7
PHILIPS HeartStart FRx models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PHILIPS HeartStart FRxAutomated external defibrillators (non-wearable)26 deaths1,586 reports
- PHILIPS HeartStart FRx 861304Automated External Defibrillators (Non-Wearable)6 deaths356 reports
- PHILIPS HeartStart FRx 861339Automated External Defibrillators (Non-Wearable)1 report
Recent PHILIPS HeartStart FRx adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Philips Electronics North America Corporation products
All Philips Electronics North America Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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