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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that the during functional testing, the associated the device failed for high impedance using these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The 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 using a test device without duplicating the report.The test device log was downloaded with no errors registered.A visual inspection of the electrodes found no discrepancies.The elctrode impedance measured within specification.The electordes were scrapped after testing.Analysis of reports of this type has not identified an increase in trends.

• Brand Name: ELECTRODES, DEFIBRILLATION AED, G3
• Common Device Name: ELECTRODES
• 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: 17182293
• Report Number: 2112020-2023-00542
• Device Sequence Number: 12385922
• Product Code: MKJ
• UDI-Device Identifier: 00812394020911
• UDI-Public: 00812394020911
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 06/01/2023

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 Expiration Date: 01/28/2024
• Device Model Number: 9131-001
• Device Catalogue Number: 9131-001
• Device Lot Number: 210706-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown