BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT DOG PATIENT WARMING SYSTEM

    MDR report key: 2823640 · Received September 2, 2010

    Report

    Report Number
    3005857264-2010-00001
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Product Code
    DWJ
    PMA / PMN Number
    K052392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL WARMING BLANKETS AT THE FACILITY WHERE THE MALFUNCTION OCCURRED WERE RETRIEVED FOR EVAL. ANALYSIS OF THE MALFUNCTIONING BLANKET DETERMINED THAT AN INTERNAL POWER CONDUCTOR HAD BROKEN, CREATING THE OBSERVED LOCALIZED OVERHEATING. THE OTHER BLANKETS AT THE FACILITY (N=16) WERE INVESTIGATED TO DETERMINE IF THEY EXHIBITED ANY PHYSICAL EVIDENCE WHICH COULD BE PREDICTIVE OF A SIMILAR MALFUNCTION. NONE OF THE OTHER WARMING BLANKETS EXHIBITED AN OBVIOUS PHYSICAL DEFECT IN THE INTERNAL POWER CONDUCTOR. IN ADDITION, INFRARED THERMOGRAPHY DID NOT DETECT ANY WIRE DEFECTS THAT MAY HAVE BEEN HIDDEN BY THE ELECTRICAL INSULATION. THE INITIAL INVESTIGATION INDICATES THAT THE MALFUNCTION IS RELATED TO ONE SPECIFIC PART, AND THAT COMPARABLE PARTS FROM THE SAME FACILITY DID NOT EXHIBIT SYMPTOMS OF A SIMILAR MALFUNCTION. TO DATE, NO OTHER RETURNED BLANKETS HAVE EXHIBITED THIS MALFUNCTION. COMPARABLE PRODUCT FROM OTHER FACILITIES WILL BE RETRIEVED FOR EVAL (CAPA (B)(4)), AND RETURNS WILL CONTINUE TO BE MONITORED FOR SIMILAR FAILURES.

    Description of Event or Problem · 1

    THE PT WAS BEING WARMED USING A B104 FULL BODY WARMING BLANKET, SN (B)(4). THE NURSE NOTICED A BURNING SMELL COMING FROM THE PT AND WHEN SHE LIFTED THE WARMING BLANKET SHE THEN NOTICED SMOKE COMING FROM THE BLANKET. SHE IMMEDIATELY REMOVED THE BLANKET FROM THE PT AND DISCONNECTED IT FROM THE CONTROLLER. THE WARMING BLANKET HAD A SMALL BURN HOLE IN IT ON THE BLACK SIDE OF THE BLANKET, BOTTOM SIDE. THE PT WAS INSPECTED FOR ANY INJURIES FROM THE BLANKET AND NONE WERE FOUND, THE PT DID NOT SUFFER ANY INJURY FROM THE WARMING BLANKET MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOT DOG PATIENT WARMING SYSTEM B104: FULL BODY BLANKET DWJ B104 0801

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other