BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M BAIR HUGGER WARMING UNIT 775

    MDR report key: 3071135 · Received April 8, 2013

    Report

    Report Number
    2110898-2013-00016
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    DWJ
    PMA / PMN Number
    K001149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LITTLE INFORMATION WAS PROVIDED TO THE MANUFACTURER REGARDING THE SPECIFIC PT. NO INJURY WAS REPORTED. UNIT WAS RETURNED FOR ANALYSIS AND ANALYSIS IS IN PROGRESS AND NOT YET COMPLETED. METHOD: ACTUAL DEVICE NOT EVALUATED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. INCONCLUSIVE-INVESTIGATION IN PROGRESS. THE WARMING UNITS ARE REUSABLE DEVICES FOR THEY ARE EQUIPMENT.

    Description of Event or Problem · 1

    IT WAS NOTED AT THE END OF A SURGICAL PROCEDURE THAT THE PT'S TEMPERATURE HAD DROPPED, BUT THERE WAS NO ADVERSE EVENT FOR THE PT. THE HOSPITAL USED A DIFFERENT WARMING UNIT AND WARMED THE PT. NO ADDITIONAL INFORMATION WAS AVAILABLE. IT WAS REPORTED THAT UNIT APPEARED TO BE OPERATING AT AMBIENT TEMPERATURE. THE UNIT WAS RETURNED TO MANUFACTURER AS PART OF AN EXCHANGE PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142731 3M BAIR HUGGER WARMING UNIT 775 SYSTEM, THERMAL REGULATING DWJ 870.5900 DWJ 3M HEALTH CARE 775 23692

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other