MAUDE Adverse Event Report: 3M HEALTH CARE 3M BAIR HUGGER¿ WARMING UNIT; HYPER/HYPOTHERMA SYSTEM

Model Number 775

Device Problem Temperature Problem (3022)

Patient Problems Hypothermia (1915); No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Expiration date is not applicable to the unit.The device has not been returned by the customer for evaluation.Multiple attempts have been made to contact the individual who reported the incident.To date, no response has been received.No additional information has been provided.The device was not returned for evaluation, therefore unit fault codes, if applicable, could be not be investigated or verified.Trending was reliably used taking the history of the customer complaint type.The failure rate for the reported incident is low.3m will continue to monitor the product line for future failure trends.If additional information becomes available a follow up report will be submitted.

Event Description

A hospital risk manager alleged anesthesia notified the cath lab a (b)(6) year old patient (gender not specified) developed hypothermia while using a 3m ¿ bair hugger ¿ warming unit, model 775, serial # (b)(4).No details are known as to the temperature or the duration of heating during this time.3m ¿ bair hugger ¿ blanket model number used was not specified.Exact date of incident was not specified.Event was reported to have occurred in (b)(6) 2018.The employee alleged the lowest patient temperature recorded was 91.4° f.The employee alleged the bair hugger ¿ appeared to be blowing ambient air while on standby mode.Medical treatment was not specified.

• Brand Name: 3M BAIR HUGGER¿ WARMING UNIT
• Type of Device: HYPER/HYPOTHERMA SYSTEM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave.; 3m center, building 275-5w-06; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 55344
• Manufacturer Contact: dianne gibbs ; 2510 conway ave; 3m center, building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8204509
• MDR Text Key: 131728587
• Report Number: 2110898-2018-00115
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2018

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
• Device Operator: Health Professional
• Device Model Number: 775
• Device Catalogue Number: 77500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR