MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART AED G3 PLUS AUTOMATIC AED; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	9390A-1001
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while anticipating the treatment of an already deceased 33-year-old male patient, the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.

• Brand Name: POWERHEART AED G3 PLUS AUTOMATIC AED
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield MA 53531 9692
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; +1(978)421-9552
• MDR Report Key: 25456374
• Report Number: 2112020-2026-00282
• Device Sequence Number: 15634739
• Product Code: MKJ
• UDI-Device Identifier: 00812394021086
• UDI-Public: (01)00812394021086
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 9390A-1001
• Was Device Available for Evaluation?: No
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• 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 Age: 33 YR
• Patient Sex: Male
• Patient Weight: 218 LB