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

Model Number 9355-0954-01

Device Problem Arcing of Electrodes (2289)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The electrodes were returned to zoll medical corporation for evaluation.Inspection of the electrodes found creases and unshaven hair stuck to the anterior pad.This report has been attributed to poor patient preparation.Our instructions for use for the electrodes calls out the importance of good placement to the patient's skin and states: remove excess chest hair.Clip if necessary to maximize gel to skin contact.Excessive hair can inhibit good coupling contact, which can lead to the possibility of acring and skin burns.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to cardiovert a 76-year-old male patient, an arc was seen from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• Brand Name: ELECTRODES, ONESTEP COMPLETE
• Type of Device: ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 17328162
• MDR Text Key: 319205099
• Report Number: 1218058-2023-00124
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9355-0954-01
• Device Catalogue Number: 9355-0954-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male