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 Atrial Fibrillation (1729)

Event Date 07/27/2023

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 cardiovert an 84-year-old female patient, an arc (loud pop) was heard from the electrode pad.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation evaluated the electrode pads and the customer's report was not replicated or confirmed.Visual inspection of the electrode pads observed some slight discoloration around part of the outer edges of the tin of the front pad.There were no signs of any burns or sparking.The pads passed continuity testing.The pads were scrapped.No clinical data was provided for review.During defibrillation therapy, sparks could occur due to a high measured patient impedance.This could be due to many reasons including, but not limited to, how the skin is prepared, how the electrodes are applied, or poor coupling.Electrode labeling provides instructions for proper electrode application technique.Poor adherence and /or air under the electrodes can lead to the possibility of arcing.It is likely that there is poor coupling between the pads and the patient, but without the device log or additional information regarding patient prep or pads application, root cause cannot be determined.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
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 17584591
• MDR Text Key: 321541042
• Report Number: 1218058-2023-00132
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: 00847946016661
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 1823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female