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

Model Number	2330
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with active chest pain.Procedure electrocardiogram (ekg).The ekg electrodes would not adhere to patient skin.The ones that did stick, were not conducting well.This took almost 15 minutes to get an adequate ekg, delay in procedure.No known harm to patient.

• Brand Name: RED DOT
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway avenue; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 20168414
• Report Number: 20168414
• Device Sequence Number: 8250248
• Product Code: DRX
• UDI-Device Identifier: 10707387195455
• UDI-Public: (01)10707387195455(17)260506(10)202605FG
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/13/2024
• Report Date (Section F): 08/13/2024

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: Health Professional
• Device Model Number: 2330
• Device Catalogue Number: 2330
• Device Lot Number: 202605FG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 08/13/2024