MAUDE Adverse Event Report: 3M HEALTH CARE 3M RED ROD ELECTRODES; ECG ELECTRODE

Model Number 2670-5

Device Problem Material Separation (1562)

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

Event Date 12/06/2018

Event Type  malfunction  

Event Description

Snap separates from the ecg electrode.This has occurred numerous times.Attempts to notify the mfr were unsuccessful.

• Brand Name: 3M RED ROD ELECTRODES
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE ; st. paul MN
• MDR Report Key: 8186317
• MDR Text Key: 131405208
• Report Number: MW5082364
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2020
• Device Model Number: 2670-5
• Device Catalogue Number: 2670-5
• Device Lot Number: 202007EM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1