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

Model Number	G5S-80A
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2025
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 while attempting to defibrillate a patient (age and gender unknown) the device displayed a "maintenance required" message.The pads weren't expired and the battery pack is at 47%.After analyzing, the unit failed to discharge.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.Review of the device history log showed no evidence of a device malfunction.The customer indicated the event date was 06/09/2025; however, the only recent logged patient event is 06/07/2025.There are no critical errors logged for that date.The device never prompted for shock delivery, as the required conditions were not met.The "maintenance required" prompt occurred after the event, when the lid was opened without pads attached.The device operated as expected.Analysis of reports of this type has not identified an increase in trend.

• 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: 22344754
• Report Number: 2112020-2025-00449
• Device Sequence Number: 15583363
• Product Code: MKJ
• UDI-Device Identifier: 00812394021277
• UDI-Public: (01)00812394021277
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 06/09/2025

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-80A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2018
• 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