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

Model Number 87500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/19/2024

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 336866842
• Report Number: 2110898-2024-00011
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00707387803438
• UDI-Public: 00707387803438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female