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

Model Number 8900-0224-01

Device Problem Arcing of Electrodes (2289)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2015

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 defibrillating a male patient (age unknown), an arc was seen from the electrode pads.Complainant indicated that the clinician observed ecg electrodes stuck underneath the anterior electrode pad.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

After further investigation of the facts provided by the customer, it was determined that the customer used ecg monitoring leads underneath the electrode pads during defibrillation.Please reference the attached preparation for use pamphlet that instructs users to take the necessary precautions to reduce these factors.This report has been attributed to improper use of the device by the end user.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP COMPLETE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 5285708
• MDR Text Key: 33939610
• Report Number: 1218058-2015-00143
• 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,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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