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

Model Number 8900-4006

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

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 a patient (age & gender unknown), a spark was emitted from the electrode pad.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The propadz radiolucent electrodes were returned to zoll medical corporation for evaluation.Inspection of the pads observed evidence that a spark occurred due to an air pocket between the pads and the patient.The electrodes were scrapped at zoll.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Poor adherence and/or air under the electrodes can lead to the possibility of sparking/arcing and skin burns.The instructions for use on the pro-padz radiolucent electrodes label states, "apply electrode by attaching one edge securely to the patient and rolling smoothly from that edge to the other.Be careful not to trap any pockets of air between the gel and skin." 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
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 13043026
• MDR Text Key: 282714985
• Report Number: 1218058-2021-00144
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/05/2023
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 3221A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• 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