MAUDE Adverse Event Report: 3M COMPANY 3M¿ BAIR HUGGER¿ PATIENT ADJUSTABLE WARMING UNIT; SYSTEM, THERMAL REGULATING

Model Number	87500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient allegedly experienced postoperative 2nd degree burns to the abdomen and right leg with the use of the 3m¿ bair hugger¿ patient adjustable warming unit 87500.
Additional Manufacturer Narrative
The device was evaluated, and no fault was found with the device related to this event.The device passed the critical safety over-temperature (ot) test and shuts off when the output air temperature exceeds 47°c.No damage or degradation observed to pcba, heater, or blower critical components.3m will continue to monitor.

• Brand Name: 3M¿ BAIR HUGGER¿ PATIENT ADJUSTABLE WARMING UNIT
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 55344
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 18836126
• Report Number: 2110898-2024-00011
• Device Sequence Number: 17953416
• Product Code: DWJ
• UDI-Device Identifier: 00707387803438
• UDI-Public: 00707387803438
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K060865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 87500
• Device Catalogue Number: 87500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female