PHILIPS HeartStart Adult SMART Pads Heartstart Adult Smart Pads CartridgeRecalls & reported problems
Philips Electronics North America Corporation · HeartStart Adult SMART Pads Cartridge · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00884838023741), received between Sep 30, 2021 and Jan 11, 2023 — classified as 1 death, 13 malfunctions.
The most frequently reported specific device problem is “Material Separation” (9 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.
Most reported problems
Device problems
- Material Separation9
- Failure of Device to Self-Test5
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Cardiac Arrest1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
IT HAS BEEN REPORTED THAT THE AED IS NOT WORKING PROPERLY AND STATED THAT THE PADS ARE NOT USABLE WHEN BLUE I BUTTON IS PRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16135778 ↗MalfunctionNov 10, 2022Material Separation; Material Separation
IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15776249 ↗MalfunctionSep 27, 2022Material Separation; Material Separation
IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15495015 ↗DeathAug 2, 2022Material Separation; Material Separation
DURING A PATIENT USE EVENT, IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS. THE PATIENT DID NOT SURVIVE.
Patient problems: Cardiac Arrest
MAUDE report 15152993 ↗MalfunctionMar 8, 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 13698951 ↗MalfunctionFeb 8, 2022Material Separation; Material Separation
IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13486873 ↗MalfunctionFeb 4, 2022Material Separation; Material Separation
IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13450690 ↗MalfunctionFeb 3, 2022Material Separation; Material Separation
IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13443044 ↗MalfunctionFeb 3, 2022Material Separation; Material Separation
IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13441825 ↗MalfunctionFeb 2, 2022Material Separation; Material Separation
IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13429939 ↗MalfunctionJan 27, 2022Material Separation; Material Separation
IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13370031 ↗MalfunctionDec 7, 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 12953826 ↗MalfunctionOct 13, 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 12625308 ↗MalfunctionSep 30, 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 12558303 ↗
Other Over-The-Counter Automated External Defibrillator devices
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- PHILIPS HeartStart HOME M5068APhilips Electronics North America Corporation · Over-The-Counter Automated External Defibrillator42 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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