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

Model Number	G5S-80C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during functional testing, the device displayed a red "x" indicator.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Review of the device activity logs makes it clear the device presented an error in (b)(6) 2023 where the end result was that the device code indicator was red and was beeping.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.We can identify from the log that this device appears to have been left idle in a non-usable state for at least 2 years prior to reporting it to zoll.Zoll medical corporation evaluated the device.The device was put through extensive testing including daily/weekly/monthly testing, on/off current testing, on/off current testing, and defibrillation cycling without duplicating the report.The batteries were not returned for evaluation.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: POWERHEART G5 KIT, SEMI, US ENG/ESP LA
• Common Device Name: AUTOMATED EXTERNAL DEFRIBRILLATOR
• 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: 22936689
• Report Number: 2112020-2025-00573
• Device Sequence Number: 21298301
• Product Code: MKJ
• UDI-Device Identifier: 00812394021284
• UDI-Public: (01)00812394021284
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 08/11/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2017
• 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