MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	G5S-80C
Medical Device Problem Codes	Failure to Charge (1085); Use of Device Problem (1670)
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 the investigation is closed as an unaddressed advisory message, as log show it occurred since 06/05/25.The main board was replaced as a precaution.Our evaluation of the unit verified the error during testing.We determined the main board to be the cause of the fault and replaced it to resolve the reported problem.Evaluation of the main board could not reproduce and during testing.Sent board to scrap.No emerging trend based on similar reports.
Event or Problem Description
Complainant alleged that during functional testing, the device prompted an "hv charge and hold" and "hv charger test capacitor not holding charge" message.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD
• 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: 25092899
• Report Number: 2112020-2026-00186
• Device Sequence Number: 18631801
• Product Code: MKJ
• UDI-Device Identifier: 00812394021284
• UDI-Public: (01)00812394021284
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/17/2026

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-80C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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