Powerheart® G5 Automatic AED G5A-01P0Recalls & reported problems
Cardiac Science Corporation · Powerheart® G5 Automatic AED · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812394020164), received between Mar 30, 2022 and Dec 5, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (4 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
- Unable to Obtain Readings4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2023Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "ECG FAULT -501" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18267134 ↗MalfunctionApr 6, 2022Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "ECG FAULT -501" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14027817 ↗MalfunctionMar 30, 2022Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13954922 ↗MalfunctionMar 30, 2022Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13954284 ↗
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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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