• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ BAIR HUGGER¿ FULL ACCESS UNDERBODY WARMING BLANKET DISPOSABLE THERMAL BLANKET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

3M HEALTH CARE 3M¿ BAIR HUGGER¿ FULL ACCESS UNDERBODY WARMING BLANKET DISPOSABLE THERMAL BLANKET Back to Search Results
Model Number N/A
Device Problems Device Issue (2379); Improper Device Output (2953); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hypothermia (1915)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative

This product does not include an expiration date for it is sold as a non-sterile product. No formal number has been provided from fda as to our recall. The following caution statement is included in the instructions for use regarding 63500 blanket. 3m was not able to confirm if patient was monitored as suggested in our labeling. " caution: to reduce the risk of thermal injury, hyperthermia or hypothermia: 3m recommends continuously monitoring core temperature. In the absence of continuous monitoring, monitor the temperature of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol. ".

 
Event Description

Patient went into hypothermia after use of a warming blanket. The patient's hypothermia temperature was at 35. 2°c. This patient was previously operated for an endoluminal mitral valve. Then, in post-operative phase, the patient had to be maintained under anesthesia and sent to the intensive care unit until recovery of a normal body temperature. It was observed the left lateral bolster seal to the distal end of the blanket did not allow for air circulation in the area of the patient's legs and along side the patient's body which resulted in a lack of warming.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3M¿ BAIR HUGGER¿ FULL ACCESS UNDERBODY WARMING BLANKET
Type of DeviceDISPOSABLE THERMAL BLANKET
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 Key7229320
MDR Text Key98630068
Report Number2110898-2018-00014
Device Sequence Number1
Product Code DWJ
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK041686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 01/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number63500
Device LOT NumberR10362
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/26/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/23/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/30/2018 Patient Sequence Number: 1
-
-