BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 SNUGGLE WARM CONVECTIVE WARMING BLANKET

    MDR report key: 1972628 · Received January 19, 2011

    Report

    Report Number
    2183502-2010-00662
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 13, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K011907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE REPORT, THE STAFF HAS BEEN RE-TRAINED TO NOT REST THE HOSE ON PTS DURING A PROCEDURE. SINCE THE TRAINING, THERE HAVE BEEN NO FURTHER OBSERVATION OF ERYTHEMA. THE INITIAL REPORTER DID NOT KNOW THE REORDER NUMBER OR LOT NUMBER OF THE DEVICE AND DOES NOT INTEND TO RETURN ANY PRODUCT FOR EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING USE OF A CONVECTIVE WARMER DURING A PROCEDURE, THE HOSE RESTED ON THE PT'S LEGS. AN UPPER BODY SNUGGLE WARM BLANKET WAS IN USE. IT WAS LATER NOTED THAT THE PT'S LEG WAS REDDENED WHERE THE CORRUGATED LOOPS OF THE HOSE RESTED. NO TREATMENT WAS GIVEN IN RESPONSE TO THE REDDENED AREA WHICH RESOLVED WITH NO INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 SNUGGLE WARM CONVECTIVE WARMING BLANKET DWJ -- CONVECTIVE WARMER DWJ SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK