MAUDE Adverse Event Report: 3M COMPANY RED DOT ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Lot Number 202208EO

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

3m red dot electrodes 5 lead package.Center black lead comes out and breaks apart form electrode, becomes stuck in the leadset.Fda safety report id # (b)(4).

• Brand Name: RED DOT ELECTRODES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 10836920
• MDR Text Key: 216416468
• Report Number: MW5097851
• Device Sequence Number: 1
• Product Code: DRX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2022
• Device Lot Number: 202208EO
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1