BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL II

    MDR report key: 1082817 · Received July 17, 2008

    Report

    Report Number
    1082817
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 16, 2008
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    COOLING BLANKET WAS PLUGGED INTO WALL. APPEARED TO BE WORKING FOR ABOUT 5 MINUTES. HEARD A LOUD POP AND SAW SEVERAL SHOWERS OF SPARKS RADIATING FROM UNDERNEATH THE BED. HEARD ANOTHER LOUD POP AND COOLING BLANKET SHUT OFF. SMALL AMOUNT OF SMOKE WAS SEEN. NO BURNS, FLAMES, OR FURTHER SPARKS WERE SEEN. PLANT OPERATIONS CAME TO ROOM AND UPON INSPECTION OF EQUIPMENT A FRAYED WIRE WAS NOTED. EQUIPMENT WAS TAGGED AND REMOVED FROM SERVICE. NO HARM TO PATIENT NOTED. BIOMED DETERMINED THAT THE EVENT OCCURRED AS A RESULT OF CORDS GETTING ENTANGLED WITH THE PATIENT BED; AND THAT THERE WAS NO PRODUCT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLANKETROL II HYPER-HYPOTHERMIA SYSTEM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 222R *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR