MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP PACING, SINGLE, R SERIES

Model Number	8900-0222-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to pace a (b)(6) female patient, after removing the electrode pads, burns were found on the patient's skin.Patient sustained burnmarks.This is all the information available.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and updating information submitted on the initial medwatch report.Please reference section f (user medwatch form).Evaluation: the customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.Instructions for use indicates to change the electrodes after 8 hours of pacing and to evaluate the patient every 30 minutes.Electrode labeling calls out the importance of good placement on the patient and provide 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 that a burn will not occur and burns from defibrillation is an expected risk.

• Brand Name: ELECTRODES, ONESTEP PACING, SINGLE, R SERIES
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11614820
• Report Number: 1218058-2021-00042
• Device Sequence Number: 3356091
• Product Code: MKJ
• UDI-Device Identifier: 00847946016258
• UDI-Public: 00847946016258
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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
• Operator of Device: Other
• Device Model Number: 8900-0222-01
• Device Catalogue Number: 8900-0222-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other