BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINCINNATI SUB-ZERO WARM AIR DEVICE

    MDR report key: 1386570 · Received April 3, 2009

    Report

    Report Number
    MW5011119
    Event Type
    Malfunction
    Date Received
    April 3, 2009
    Date of Event
    February 19, 2009
    Report Date
    April 3, 2009
    Manufacturer
    CSZ PRODUCTS, INC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SPINAL FUSION L4-5 FUSION 3-4 WEEKS AGO, SEEN FOR POST OP VISIT. PT HAD DEVELOPED A LEFT SCAPULAR BURN MEASURING 4-5 INCHES IN DIAMETER WITH SHARP BORDERS (FORTUNATELY FIRST DEGREE WHICH HEALED UP WITH LOCAL CARE). CONCERN THAT THE WARMING BLANKET USED DURING THE SURGERY MAY HAVE CAUSED THE BURN. IN 2009, MEETING WITH REP, CRNA, ANESTHESIA, CLINICAL ENGINEERING, SKIN CARE RN. PATTERN OF THE BURN SUGGESTED THAT PREP SOLUTION POOLING UNDER DRAPES MAY HAVE CAUSED CHEMICAL BURN, UNCLEAR IF TAPE WAS ALSO A CONTRIBUTING FACTOR. BSN, RISK MANAGER, THIS INFORMATION IS BEING SENT AT THE REQUEST OF FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCINNATI SUB-ZERO WARM AIR DEVICE WARMING BLANKET DWJ CSZ PRODUCTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other