Powerheart® G5 Semi Automatic AED G5S-01ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812394021239), received between Oct 6, 2025 and Aug 12, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Feb 13, 2025Class IIOpen, Classified

   The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

   Z-1322-2025 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

2. May 31, 2024Class IIOpen, Classified

   G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest

   Z-2324-2024 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Communication or Transmission Problem

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "E05" ERROR MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222398 ↗
• MalfunctionAug 5, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50140788 ↗
• MalfunctionMay 7, 2026Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "SELF TEST FAILURE FOR Z SAMPLE < THRESHOLD" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116364 ↗
• MalfunctionOct 6, 2025Unable 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 23228438 ↗