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

Lot Number (10)202212FA

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Patient needed to be hooked up to telemetry to administer iv hypertensive medication, when placing electrodes on the telemetry leads the buttons on the electrodes are ripping out of the electrode and getting stuck into the telemetry leads.This happened 3 out of the 5 electrode stickers.New leads removed from another package, no harm to patient.

• Brand Name: RED DOT
• 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: 11776201
• MDR Text Key: 249011106
• Report Number: 11776201
• Device Sequence Number: 1
• Product Code: DRX
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: (10)202212FA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1