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

Model Number 2670-5

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 11/11/2018

Event Type  malfunction  

Event Description

A patient in the icu was being prepared for synchronized cardioversion using defibrillation on the unit and there was a delay due to 3m red dots being stuck in the defibrillator leads.It appeared as though the connectors had ripped off the sticky part of the red dots making it difficult to attach new red dots.The old ones had to be removed using kelly clamps.

• Brand Name: 3M RED DOT REPOSITIONABLE MONITORING ELECTRODE
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 8132586
• MDR Text Key: 129313924
• Report Number: 8132586
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387499966
• UDI-Public: (01)10707387499966
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2670-5
• Device Catalogue Number: 2670-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA