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

Model Number	2670-5
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/11/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 8132586
• Report Number: 8132586
• Device Sequence Number: 2081593
• Product Code: DRX
• UDI-Device Identifier: 10707387499966
• UDI-Public: (01)10707387499966
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2018
• Report Date (Section F): 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2670-5
• Device Catalogue Number: 2670-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/28/2018