MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE; DEFIB/PACING ELECTRODE

Model Number 8900-4006

Device Problem Arcing of Electrodes (2289)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2020

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 cardiovert a (b)(6) male patient, an arc was heard from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The pro padz solid gel radiolucent multifunction electrodes were returned to zoll medical corporation opened and adhered together.Visual inspection found a heavy presence of hair on the adhesive of the electrodes and discoloration on the conductive plates indicating the occurrence of discharge.The electrodes appear to be functional although sent to zoll in an unsealed package which dried out the gel.All indications suggest patient preparation was a factor.The electrode pads were scrapped.Zoll recommends that patients are cleaned and hair clipped prior to applying electrode pads to assure good coupling of electrode to skin contact.Poor adherence and/or air under the electrodes can lead to the possibility of arcing and skin burns.This investigation was closed as improper patient preparation prior to the application of the electrodes.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10472187
• MDR Text Key: 204985482
• Report Number: 1218058-2020-00066
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: 00847946016661
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/22/2021
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 0420A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR