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

Model Number	9131-001
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 a routine shift check by a clinician, the device was unable to detect the attached pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The electrode pads were returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The electrodes passed the power on self test with no errors and passed functional stress testing connected to a test device.No errors were found.A visual inspection found no discrepancies.The electrode impedance measured within specification.The electrodes were scrapped.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
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 16491368
• Report Number: 2112020-2023-00149
• Device Sequence Number: 6363540
• Product Code: MKJ
• UDI-Device Identifier: 00812394020911
• UDI-Public: 00812394020911
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/13/2023

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
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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