MAUDE Adverse Event Report: 3M COMPANY BAIR HUGGER; SYSTEM, THERMAL REGULATING

Model Number 775

Device Problems Product Quality Problem (1506); Self-Activation or Keying (1557)

Patient Problem Hypothermia (1915)

Event Date 09/28/2018

Event Type  malfunction  

Event Description

Anesthesia notified cath lab staff that patient developing hypothermia.Bair hugger appeared to be blowing ambient air on standbye mode.Lowest patient temp 91.4.

• Brand Name: BAIR HUGGER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 8101255
• MDR Text Key: 128257560
• Report Number: 8101255
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2018
• Date Report to Manufacturer: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA