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

Model Number 8900-4006

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 06/18/2021

Event Type  Injury  

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)-year-old patient (gender unknown), an popping noise was heard from the electrode pads and after removing the electrode pads, burns were found on the patient's skin.Silvadene ointment applied to patient per physician's order and patient sent home with silvadene ointment and tylenol to use at home.Patient sustained burnmarks.

Manufacturer Narrative

The pro-padz were received at zoll medical corporation with signs of use.The customer's report was not replicated or confirmed.The electrodes were evaluated and found no signs of assembly malfunction, arcing, sparks, or that the patient received a burn.The gel on the electrodes was pulled back to evaluate the tin and found no signs of arcing.Typically, when there are arcs, there is obvious evidence left on the tin plating.The electrodes passed continuity testing without duplicating the report.The electrodes were scrapped at zoll.Burns and skin reddening are not an unexpected outcome and can result for many reasons including, but not limited to: how the skin is prepared, how long the electrodes are applied, and how the electrodes are applied.Furthermore, cardioversion attempts typically lead to more occurrences of reddening of the skin due to inherently better profusion in the patient.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: 12177695
• MDR Text Key: 261911069
• Report Number: 1218058-2021-00089
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/23/2022
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 1721D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR