MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION G3 PLUS, AED, AHA 2010, ENGLISH; AUTOMATED EXTERNAL DEFIBRILATOR

Model Number	9390E-1001
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during functional testing, the device failed impedance testing.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated.The device was put through extensive testing including daily/weekly/monthly testing and stress testing without duplicating the report.An internal inspection found no discrepancies.The error was cleared from the logs.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: G3 PLUS, AED, AHA 2010, ENGLISH
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILATOR
• 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: 17788630
• Report Number: 2112020-2023-00779
• Device Sequence Number: 6170150
• Product Code: MKJ
• UDI-Device Identifier: 00812394020348
• UDI-Public: 00812394020348
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/31/2023

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: 9390E-1001
• Device Catalogue Number: 9390E-1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2017
• 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