PHILIPS HeartStart HOME M5068ARecalls & reported problems
Philips Electronics North America Corporation · HeartStart Home Defibrillator, HS1 · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Philips HeartStart Home defibrillator (HS1) is an over-the-counter automated external defibrillator for home use. It has 42 adverse event reports, all malfunctions, with no deaths and no injuries. The reports mostly describe the device failing its self-test, with some mentioning it not behaving as expected or failing to power on. 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
- 42
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00884838049130), received between Jan 13, 2017 and Feb 8, 2025 — classified as 42 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (25 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-Test25
- Device Operates Differently Than Expected9
- Failure to Power Up3
- Adverse Event Without Identified Device or Use Problem2
- Battery Problem1
- Defective Device1
- Electrical /Electronic Property Problem1
- Fail-Safe Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Known Impact Or Consequence To Patient16
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 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 21340140 ↗MalfunctionJul 11, 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 19718025 ↗MalfunctionApr 15, 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 19103208 ↗MalfunctionFeb 20, 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 18740517 ↗MalfunctionDec 7, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18283827 ↗MalfunctionOct 6, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17886664 ↗MalfunctionMar 15, 2023Failure 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 16547651 ↗MalfunctionDec 20, 2022Failure 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 16014578 ↗MalfunctionDec 15, 2022Failure 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 15986628 ↗MalfunctionDec 9, 2022Failure 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 15955148 ↗MalfunctionNov 30, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT HAS BEEN REPORTED THAT THE DEVICE SHOCK BUTTON MAY NOT BE FUNCTIONING AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15889804 ↗MalfunctionNov 28, 2022Failure 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 15874256 ↗MalfunctionNov 21, 2022Failure 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 15835192 ↗MalfunctionNov 7, 2022Failure 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 15745721 ↗MalfunctionOct 28, 2022Failure 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 15690470 ↗MalfunctionOct 19, 2022Failure 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 15634863 ↗MalfunctionOct 18, 2022Failure to Power Up; Failure to Power Up
IT HAS BEEN REPORTED THAT THE DEVICE DOES NOT POWER ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15629218 ↗MalfunctionOct 18, 2022Failure 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 15621164 ↗MalfunctionAug 5, 2022Failure 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 15174599 ↗MalfunctionMay 11, 2022Failure to Power Up; Failure of Device to Self-Test; Failure to Power Up; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THIS DEVICE DOES NOT POWER ON AND WILL NOT PERFORM SELF-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14359490 ↗MalfunctionMar 29, 2022Failure 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 13938031 ↗MalfunctionAug 3, 2021Failure 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 12271632 ↗MalfunctionJun 11, 2021Failure 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 11985235 ↗MalfunctionJun 2, 2021Failure 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 11920756 ↗MalfunctionJun 15, 2020Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10152752 ↗
Other Over-The-Counter Automated External Defibrillator devices
- HeartStart Heartstart HS1Philips Electronics North America Corporation · Over-The-Counter Automated External Defibrillator37 deaths3,330 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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