Powerheart® G5 Automatic AED G5A-01P1Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00812394021185), received between Oct 23, 2019 and May 1, 2024 — classified as 1 death, 17 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (8 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221616 ↗
• MalfunctionApr 18, 2024Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134092 ↗
• MalfunctionFeb 23, 2024Failure of Device to Self-Test; Operating System Version or Upgrade Problem; Failure of Device to Self-Test; Operating System Version or Upgrade Problem

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE POWER-ON UPGRADE AND FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767584 ↗
• MalfunctionFeb 12, 2024Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "ECG FAULT -501" ERROR MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691045 ↗
• MalfunctionJan 23, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562907 ↗
• MalfunctionSep 21, 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 17787719 ↗
• MalfunctionSep 21, 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 17787713 ↗
• MalfunctionAug 30, 2023Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED AN "HV CAP IDLE TEST FAILURE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649663 ↗
• MalfunctionAug 11, 2023Failure to Charge; Failure to Charge

  COMPLAINT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED AN "HV CAP IDLE TEST FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509763 ↗
• MalfunctionAug 4, 2023Use of Device Problem; Use of Device Problem

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED AN "HV CAP IDLE TEST FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459098 ↗
• MalfunctionMay 19, 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 16969707 ↗
• MalfunctionDec 23, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "ECG FAULT -501" ERROR MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 16042706 ↗
• MalfunctionNov 22, 2022Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS AND PROMPTED AN "HV DUMP FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847209 ↗
• MalfunctionJun 27, 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 14836552 ↗
• MalfunctionFeb 16, 2021Unable 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 11334898 ↗
• MalfunctionNov 19, 2020Battery Problem; Battery Problem

  COMPLAINANT ALLEGED THAT DURING INCOMING TESTING, THE DEVICE DISPLAYED A "BATTERY HIGH VOLTAGE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10870461 ↗
• MalfunctionDec 12, 2019Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  A (B)(6) MONTH OLD BABY WAS BROUGHT INTO A WALK IN CENTRE (WIC) BY THE MOTHER. THE TRIAGE NURSE NOTED THE BABY WAS MOTTLED AND BLUE. THE NURSE TOOK THE BABY, SHOUTED FOR HELP, AND AN AMBULANCE WAS CALLED. BABY WAS HAVING APNEIC EPISODES, BUT A PULSE WAS STILL PRESENT. NURSING STAFF DELIVERED STIMULATION TO THE BABY AND THE BABY STARTED TO BREATHE, BUT WAS STILL HAVING APNEIC EPISODES; RESCUE BREATHS WERE NOT ADMINISTERED. AED PADS WERE APPLIED IN THE A-P POSITION ON THE BABY AND THE RHYTHM ANALYSIS STATED NO SHOCK ADVISED. AFTER APPROXIMATELY SEVEN (7) MINUTES, THE AED ANALYZED THE BABY'S RHYTHM, STATED SHOCK ADVISED, AND A SHOCK WAS GIVEN. THE STAFF REPORTED THE BABY WAS BREATHING AND HAD A PULSE THROUGHOUT THE EVENT. THE CUSTOMER WANTS TO KNOW IF THERE WAS AN ISSUE WITH THE ANALYSIS OF THE RHYTHM AND WHY THE AED SHOCKED WHEN IT DID AS THERE WERE COMPLEXES ON THE ECG TRACE. THE BABY WAS TRANSFERRED TO THE HOSPITAL AND WAS STILL ALIVE WHEN THE EVENT WAS REPORTED TO CARDIAC SCIENCE.

  Patient problems: Apnea

  MAUDE report 9462188 ↗
• DeathOct 23, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS INITIALLY REPORTED TO CARDIAC SCIENCE THAT DURING A RESCUE THE STAFF AND PARAMEDIC WERE SHOCKED BY THE AED BECAUSE NONE OF THEM HEARD THE AED GIVE PROMPTS THAT A SHOCK WAS GOING TO BE DELIVERED. MORE DETAILED DESCRIPTIONS OF THE EVENT WERE PROVIDED BY TWO (2) OF THE MEDICAL STAFF WHO HELPED PERFORM THE RESCUE. ONE OF THE RESCUERS REPORTED THAT AFTER THE PATIENT WENT DOWN SHE IMMEDIATELY COMMENCED CHEST COMPRESSIONS WHILE THE EMERGENCY TROLLEY WAS FETCHED AND THE AED SET UP. CPR CONTINUED FOLLOWING INSTRUCTION FROM THE AED. THE AED DID PROMPT TO STAND CLEAR AND CPR CONTINUED FOLLOWING SHOCK DELIVERY. LATER DURING CPR THE PATIENT JUMPED AS HE WAS SHOCKED BY THE DEFIBRILLATOR. THE RESCUER WAS NOT AWARE OF ANY CHANGE IN SENSATION BUT JUMPED BACK AS DID THE OTHER RESCUER. THE DEFIBRILLATOR HAD NOT PROMPTED THE RESCUERS TO STAND CLEAR TO PREPARE FOR SHOCK DELIVERY. PARAMEDIC CREWS AND AIR AMBULANCE STAFF TOOK OVER WITH ALS. FOLLOWING THE INCIDENT THE RESCUER WAS EXAMINED AND ALTHOUGH INITIALLY BEING TACHYCARDIC, THE ECG WAS NOT FOUND TO BE OF CONCERN. THE OTHER RESCUER REPORTED THAT CPR WAS BEING PERFORMED AND AFTER APPLYING DEFIBRILLATOR PADS THE AED PROMPTED SHOCK ADVISED TO STA

  Patient problems: Cardiac Arrest

  MAUDE report 9225852 ↗