MAUDE Adverse Event Report: 3M COMPANY 3M BAIR HUGGER; SYSTEM, THERMAL REGULATING

Model Number	63000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sterile bair hugger was placed on the lower body of the patient after e.V.H.It was brought to the attention of the circulator 31 minutes later by the surgical tech.That the warmer was blowing the warm air uncontrolled under the 3/4 sheet (covering the lower extremities of the patient) placed on top of the bair hugger.The circulator turned off the warmer unit and visualized a tear at the connecting point of the extension tube at the distal end of the rolled our bair hugger.

• Brand Name: 3M BAIR HUGGER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway avenue; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 19369474
• Report Number: 19369474
• Device Sequence Number: 18024651
• Product Code: DWJ
• UDI-Device Identifier: 00707387804145
• UDI-Public: (01)00707387804145(11)230522(17)260522(10)CB24040
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/20/2024
• Report Date (Section F): 05/20/2024

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: 63000
• Device Catalogue Number: 63000
• Device Lot Number: CB24040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White
• Date Report Sent to FDA: 05/20/2024