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 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to defibrillate a male patient (age unknown), an arc/spark was seen from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The electrode pads were received for evaluation.A visual inspection of the pads found an excessive amount of hair on both the apex and sternum pads.The pads do show evidence of arcing.The device logs were not available to confirm the energy output from the device at the time of the event.However, the amount of hair on the pads indicates poor preparation of the patient's skin prior to attachment of the pads.This would result in a higher impedance, with more energy being delivered through the pads.No electrical or mechanical malfunctions were observed during evaluation of the pads.This report has been associated with poor preparation of the patient's skin.No trend is associated with reports of this type.

• 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: 10378267
• MDR Text Key: 202014555
• Report Number: 1218058-2020-00056
• 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: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/20/2021
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 2120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1