MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP COMPLETE ELECTRODE

Model Number 8900-0214-01

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abrasion (1689); Contusion (1787)

Event Type  Injury  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.Please refer to the attached user medwatch report that zoll medical has received.

Event Description

Complainant alleged that while defibrillating a patient (age & gender unknown) during cardioversion, after removing the electrode pads, tears/abrasions were found on the patient skin.Complainant indicated serious injury of tears/abrasions found on patient's skin.

Manufacturer Narrative

The actual electrode used during the event were not returned to zoll medical coproration for evaluation.No lot number of the electrodes were provided to be able to perform retain sample testing.Additional contact with the customer for the product or information were unsuccessful.The patient's injuries were non-life threatening.Our electrode safety instruction labeling addresses the importance of good placement on the patient.Poor adherence and/or air under the electrode 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.No trend is associated with reports of this type.

• Brand Name: ONE STEP COMPLETE ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9226909
• MDR Text Key: 163597969
• Report Number: 1218058-2019-00150
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 10847946016279
• UDI-Public: 10847946016279
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-0214-01
• Device Catalogue Number: 8900-0214-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other