MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART AED G3 PLUS AUTOMATIC AED; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	9390A-1001
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Intraoperative Cardiac Valve Injury (4852)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report was observed during initial testing.The device intermittently failed testing and stressing when used with the returned g3 aed adult pads the pads will be replaced as a precaution.The device passed the final test procedure, will be recertified, and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during functional testing, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: POWERHEART AED G3 PLUS AUTOMATIC AED
• 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: 20535746
• Report Number: 2112020-2024-00868
• Device Sequence Number: 12816764
• Product Code: MKJ
• UDI-Device Identifier: 00812394020232
• UDI-Public: (01)00812394020232
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2015
• 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