MAUDE Adverse Event Report: 3M HEALTH CARE 3M BAIR HUGGER WARMING UNIT 775; HYPER/HYPOTHERMA SYSTEM, PRODUCT CODE: DWJ

Model Number 775

Device Problems Fire (1245); Device Emits Odor (1425); Device Displays Incorrect Message (2591); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been visually inspected by technical governance manager at the hospital.Device was mounted on a mobile pole-stand.There was faint evidence of a drip mark down the back of the device above the mains socket as well on the base of the pole-stand.Users reported that no liquid infusion devices were in use or attached to the stand at the time of the incident but may have been mounted in the past.3m¿ will continue to monitor.

Event Description

A hospital alleged an alarm from the wall control panel alarmed and the control panel display showed an error message of "earth fault in bay 4".Alarm was reported to the hospital.Approximately two hours later there was a metallic burning smell.After fifteen minutes of the metallic smell a spark and orange flame came from 3m¿ bair hugger warming unit 77507 that was plugged in a patient's room.There was one orange flame and then the flame self-terminated.The 3m¿ bair hugger warming unit was turned off at the wall and device was unplugged.There were no further flames and device was removed from use.No patient or staff injury was reported.

• Brand Name: 3M BAIR HUGGER WARMING UNIT 775
• Type of Device: HYPER/HYPOTHERMA SYSTEM, PRODUCT CODE: DWJ
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 55344
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 11611922
• MDR Text Key: 244917958
• Report Number: 2110898-2021-00018
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 775
• Device Catalogue Number: 77507
• Device Lot Number: 125271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1