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

Model Number	230527
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
3m ecg pads physically dry, poor signal conduction for ecg.Pads were removed from a sealed package.Delayed start time for cardiovascular operating room.Actual pads not saved.Picture is representation for the product, both from the same box with the same lot #.Manufacturer response for ecg pad, (brand not provided) (per site reporter).Will watch.

• Brand Name: 3M¿ RED DOT¿
• 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: 15461653
• Report Number: 15461653
• Device Sequence Number: 16862275
• Product Code: DRX
• UDI-Device Identifier: 10707387789333
• UDI-Public: (01)10707387789333(17)230527(10)202305EP
• 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): 08/31/2022
• Report Date (Section F): 08/31/2022

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: 230527
• Device Lot Number: 202305EP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2022
• 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: Unknown
• Date Report Sent to FDA: 08/31/2022