MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ BAIR HUGGER¿ WARMING UNIT 775; SYSTEM THERMAL REGULATING

Model Number 775

Device Problem Insufficient Heating (1287)

Patient Problem Alteration In Body Temperature (2682)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

This information was not provided by the hospital.The unit was not returned by the facility for evaluation, therefore analysis testing could not be conducted.The warming units are reusable devices for they are equipment.The unit was not returned by the facility for evaluation, therefore analysis testing could not be conducted.Taking the history of the customer complaint type, trending was reliably used to complete the analysis.The customer would see a lower temperature and code fc007 if the hose was occluded.No injury to the patient was reported.Based on trending this incident remains very low.

Event Description

A hospital employee reported a patient (age and gender not specified) was being warmed intraoperatively with 3m ¿ bair hugger¿ warming unit, model 77507.The employee alleged they noticed the patient's temperature was dropping despite the warming device being switched on to a high flow setting at 43 degrees c°.The employee alleged the digital display was reading 23 degrees c° and ambient air was being blown out.A fault verified error code fc007, indicating a faulty end hose sensor was detected.The patient did not require medical intervention.

• Brand Name: 3M¿ BAIR HUGGER¿ WARMING UNIT 775
• Type of Device: SYSTEM THERMAL REGULATING
• 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 ; 2510 conway ave; 3m center, building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8091268
• MDR Text Key: 128028909
• Report Number: 2110898-2018-00106
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K001149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• 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: 23896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2011
• 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