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

Model Number 8900-0224-01

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

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 defibrillate a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a third degree burn.The clinician treated the burn with medihoney gel and foam dressing.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, a picture of the customer's report was provided.Review of the picture did show the customer's report.The customer stated that the patient received a third degree burn and received a single treatment of topical gel and a foam wrapping.Burns occurring during defibrillation are an anticipated outcome and can result for many reasons including, but not limited to: how the skin is prepared and how the electrodes are applied.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 12153740
• MDR Text Key: 264053738
• Report Number: 1218058-2021-00087
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other