MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION ELECTRODES, DEFIBRILLATION AED, G3

Model Number	9131-001
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during functional testing, the associated device detected high impedance.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The customer has responded and indicated the electrode pads were dipsosed of.The product will not be returning to zoll.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Evaluation: two sets of g3 electrodes were returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The electrodes were put through extensive testing including functional stress testing without duplicating the report.The electrodes were scrapped as a precaution.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, DEFIBRILLATION AED, G3
• Common Device Name: ELECTRODE
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 10785963
• Report Number: 2112020-2020-00902
• Device Sequence Number: 3644732
• Product Code: MKJ
• UDI-Device Identifier: 00812394020911
• UDI-Public: 00812394020911
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/14/2020

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 Expiration Date: 05/28/2021
• Device Model Number: 9131-001
• Device Catalogue Number: 9131-001
• Device Lot Number: 181114-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 10/14/2020; 10/14/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/17/2020; 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1