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

Model Number 8900-4006

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 06/01/2021

Event Type  malfunction  

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 defibrillate a patient (age & gender unknown), after removing these electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a burn to the skin.The customer was unable to provide information on the degree of the burn.

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), after removing these electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a 1st degree burn to the skin.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h1.Evaluation: the electrode pads were returned to zoll medical corporation for evaluation.The electrodes were received opened and appeared used.The returned electrodes were able to show ecg signal as well as delivering multiple shocks when tested on a test device and simulator.Visual inspection of the electrodes did not find any discrepancies, however, presence of hair was found on the pads.The presence of hair is an indication of poor patient preparation and could have contributed to the reported problem.Review of the device log did show an indication of poor connection between the patient and the electrodes.The log also showed that the energy delivered was within specification.Please note the instructions for use provides diagrams, specific instructions on good placement and warns against placing the pads on folds of skin.Electrode labeling also provides instructions for proper electrode application 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.This report has been attributed to poor coupling of the electrode pads to the patient?s skin.There has been no increase in trend identified for reports of this nature.

• 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: 12053471
• MDR Text Key: 257893531
• Report Number: 1218058-2021-00085
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/11/2022
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 1121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other