MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 SEMI AUTOMATIC AED; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	G5S-01A
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.During the investigation it was noted that based on debug and final testing, no new evidence was found post the qa nff review.The investigation is closed as observed in device data - latched.The main board was replaced as a precaution.Evaluation of the main board did not duplicate the issue at board level testing.Sent board to scrap.It is important to note that the device will communicate to the user that it is not rescue ready by providing an auditory beep every 30 seconds and displaying a red rescue ready (nvi) indicator.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
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.

• Brand Name: POWERHEART G5 SEMI AUTOMATIC AED
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 25116364
• Report Number: 2112020-2026-00173
• Device Sequence Number: 16014851
• Product Code: MKJ
• UDI-Device Identifier: 00812394021239
• UDI-Public: (01)00812394021239
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: G5S-01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown