HeartStartRecalls & reported problems across all models
Philips Electronics North America Corporation · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,335
- Deaths reported
- 37
- Injuries reported
- 20
- Recalls
- 0
We found 3 models of HeartStart by Philips Electronics North America Corporation in the FDA's device registry (GUDID). Together they are named in 3,335 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2016 and Sep 29, 2026 — classified as 37 deaths, 20 injuries, 3,278 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (2,311 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 HeartStart problems
Device problems
- Failure of Device to Self-Test2,311
- Failure to Power Up253
- Incorrect, Inadequate or Imprecise Result or Readings178
- Device Operates Differently Than Expected110
- Inaudible or Unclear Audible Prompt/Feedback80
- Failure to Run on Battery54
- Premature Discharge of Battery41
- No Audible Prompt/Feedback32
Patient problems
- No Clinical Signs, Symptoms or Conditions2,697
- No Known Impact Or Consequence To Patient444
- Insufficient Information114
- Cardiac Arrest58
- No Patient Involvement17
- Death6
- No Information6
- Unspecified Heart Problem5
HeartStart models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HeartStart Heartstart HS1Over-The-Counter Automated External Defibrillator37 deaths3,330 reports
- HeartStart HS1 Primary BatteryAutomated external defibrillators (non-wearable)4 reports
- HeartStart FR3 Cable Link to Q CPR MeterAutomated External Defibrillators (Non-Wearable)1 report
Recent HeartStart adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939537 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939536 ↗MalfunctionSep 29, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935286 ↗MalfunctionSep 28, 2026Failure to Power Up
Philips received a complaint on the HeartStart HS1 indicating that the device was unable to boot up normally. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920279 ↗MalfunctionSep 28, 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 50910619 ↗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 50899391 ↗MalfunctionSep 25, 2026Failure to Power Up
It has been reported that the device will not power up.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893320 ↗MalfunctionSep 24, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890284 ↗MalfunctionSep 22, 2026Premature Discharge of Battery
It has been reported that the device is failing self-test.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853100 ↗MalfunctionSep 22, 2026Inaudible or Unclear Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849540 ↗MalfunctionSep 21, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846716 ↗MalfunctionSep 19, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832168 ↗MalfunctionSep 19, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832078 ↗MalfunctionSep 19, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832021 ↗MalfunctionSep 19, 2026No Visual Prompts/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831689 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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