MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ZOLL ELECTRODE

Model Number	8900-000280
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Intraoperative Cardiac Valve Injury (4852)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during functional testing, the associated defibrillator was unable to detect the attached electrode pads.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The pads were received at zoll medical canada.The customer's report was duplicated and attributed to electrode pads.The pads were scrapped at zoll.A new set of pads were sent to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ZOLL ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 20493314
• Report Number: 1218058-2024-00096
• Device Sequence Number: 4095975
• Product Code: MKJ
• UDI-Device Identifier: 00847946026691
• UDI-Public: (01)00847946026691(17)290316(10)5023A
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 8900-000280
• Device Lot Number: 5023A
• Was Device Available for Evaluation?: No
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown