MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, PRO-PADZ CARDIOLOGY W/LVP GEL, SINGLE

Model Number	8900-2101-01
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/15/2020
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 while attempting to defibrillate a patient (age & gender unknown) during cardioversion, an arc was heard from the electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrodes were discarded at the customer's site and not available for evaluation.The ecg data from the event was provided.Review of the log showed a wandering baseline with ecg railing and the first shock having a high patient impedance.These errors indicate poor coupling (continuity) between the electrode pads and the patient's skin.The customer was advised to refer to the instructions for use on proper skin preparation and application of the electrodes.This claim has been closed as poor coupling (continuity).Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, PRO-PADZ CARDIOLOGY W/LVP GEL, SINGLE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9939000
• Report Number: 1218058-2020-00035
• Device Sequence Number: 700961
• Product Code: MKJ
• UDI-Device Identifier: 00847946016395
• UDI-Public: 00847946016395
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 12/02/2020
• Device Model Number: 8900-2101-01
• Device Catalogue Number: 8900-2101-01
• Device Lot Number: 2319
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1