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	Unable to Obtain Readings (1516); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged while attempting to treat a 84-year-old male patient, the device did not detect the attached electrode pads and failed for high impedance.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.Log review for the reported event showed pads were initially recognized upon device activation; however, repeated "pads off" messages and rapid impedance fluctuations occurred over approximately two minutes, consistent with poor pad-to-patient coupling.Pads were subsequently recognized with a stable ecg signal, and the device was charged but no shock was delivered.Evaluation of the device could not replicate the customer report.The device passed all testing successfully.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• 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: 24532715
• Report Number: 2112020-2026-00072
• Device Sequence Number: 8972059
• Product Code: MKJ
• UDI-Device Identifier: 00812394021284
• UDI-Public: (01)00812394021284
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 02/16/2026

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: 03/05/2026
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/11/2026
• 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 Age: 84 YR
• Patient Sex: Male