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

Model Number 8900-2101-01

Device Problem Arcing of Electrodes (2289)

Patient Problem No Information (3190)

Event Date 03/15/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event 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.

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
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9939000
• MDR Text Key: 187926363
• Report Number: 1218058-2020-00035
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016395
• UDI-Public: 00847946016395
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1