MAUDE Adverse Event Report: 3M HEALTH CARE BAIR HUGGER WARMING UNIT

Model Number 890

Device Problems Component or Accessory Incompatibility (2897); Compatibility Problem (2960)

Patient Problem Not Applicable (3189)

Event Date 01/09/2015

Event Type  malfunction  

Manufacturer Narrative

No information provided and no patient injury reported.(b)(6).Product only has a serial number and does not have an expiration date.Unit very old.This model was subject to a recall in 2010.It is believed the cord used with this unit was subject to the recall but never returned to the manufacturer.The unit was manufactured in 2005.The recall action was closed in 2012.Subsequent to recall action the nature of this event is very small.

Event Description

The power cord burnt.The unit was manufactured in 7/1/2005.

• Brand Name: BAIR HUGGER WARMING UNIT
• Type of Device: WARMING UNIT
• 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: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 5324967
• MDR Text Key: 34289915
• Report Number: 2110898-2015-00056
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 890
• Device Catalogue Number: 890000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0895-2010
• Patient Sequence Number: 1
• Patient Outcome(s): Other