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

Model Number 8900-4006

Device Problem Arcing (2583)

Patient Problems Abrasion (1689); Superficial (First Degree) Burn (2685)

Event Date 01/06/2021

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 defibrillate a (b)(6) male patient, an arc was heard from the electrode pads and upon removal of the pads, abrasions were found on the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The electrode pads were returned for evaluation.The electrodes were subjected to multiple shock tests a various joule settings that resulted in no discrepancies found.A visual inspection found no evidence of damages or any discrepancies.A photograph was provided and showed a patient's reddened skin with a curve line that is consistence with a first degree burn.The electrode pads were scrapped.Review of the device activity logs showed a patient impedance of 155 ohms with a defib impedance of 204 ohms.This is an indication of poor patient coupling between the electrode pads and the patient's skin.Our electrode labeling calls out the importance of good placement and provides instructions for proper electrode technique.Poor adherence and/or air under the electrodes can lead to the possibility of arcing and skin burns.Good skin preparation does not guarantee a burn will not occur and burns from defibrillation is an expected risk.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: 11251410
• MDR Text Key: 229342171
• Report Number: 1218058-2021-00006
• 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: 01/08/2021

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: 10/14/2021
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 4220A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR