HeartStart Heartstart HS1Recalls & reported problems
Philips Electronics North America Corporation · HeartStart HS1 Defibrillator · Class 3
All models of HeartStart (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Philips HeartStart HS1 is an automated external defibrillator, a portable device that delivers a shock to restart the heart during cardiac arrest. Its 3,300 reports mostly describe the device failing its self-test, not powering up, or running down its battery, along with unclear voice prompts. The reports include 37 deaths and 20 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
- 3,330
- Deaths reported
- 37
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,330 adverse event reports that list this exact device (DI 00884838075849), received between Nov 16, 2016 and Sep 29, 2026 — classified as 37 deaths, 20 injuries, 3,273 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (2,307 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure of Device to Self-Test2,307
- Failure to Power Up252
- 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 Conditions2,693
- No Known Impact Or Consequence To Patient443
- Insufficient Information114
- Cardiac Arrest58
- No Patient Involvement17
- Death6
- No Information6
- Unspecified Heart Problem5
Recent adverse event reports
The 25 most recent of 3,330 reports, 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 ↗MalfunctionSep 18, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829923 ↗MalfunctionSep 18, 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 50813336 ↗MalfunctionSep 17, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812611 ↗MalfunctionSep 16, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796758 ↗MalfunctionSep 16, 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 50789539 ↗MalfunctionSep 15, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779569 ↗MalfunctionSep 15, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779063 ↗MalfunctionSep 14, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765457 ↗MalfunctionSep 14, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764560 ↗MalfunctionSep 13, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747531 ↗
Other Over-The-Counter Automated External Defibrillator devices
- PHILIPS HeartStart HOME M5068APhilips Electronics North America Corporation · Over-The-Counter Automated External Defibrillator42 reports
- PHILIPS HeartStart Adult SMART Pads Heartstart Adult Smart Pads CartridgePhilips Electronics North America Corporation · Over-The-Counter Automated External Defibrillator1 death14 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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