MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT*PADZ HVP MULTI-FUNCTION CPR ELECTRODES -

Model Number	8900-0402
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
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 while attempting to monitor a (b)(6) male patient, the associated defibrillator was unable to obtain an ecg signal using these electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrode pads were returned to zoll medical corporation and the customer's report was not replicated or confirmed.The electrode pads were put through extensive testing without duplicating the report.Review of the device activity logs showed the device was powered on with pads and limb leads connected.The device captured an ecg signal via lead i for several minutes then the signal became lost.Pads on message appeared along with the patient's impedance, but the ecg view stayed in lead i; this was the case for the entire event as lead view never got changed to pads.The log showed that the patient's impedance was displayed consistently through the entire case once the pads were placed on the patient and had the user switched the view to pads, a signal would have been seen.No trend is associated with reports of this type.

• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11289367
• Report Number: 1218058-2021-00009
• Device Sequence Number: 4607379
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: 00847946016319
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: 02/05/2022
• Device Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• Device Lot Number: 0620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR