BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAIR LOW AIRLOSS THERAPY SYSTEM

    MDR report key: 2870523 · Received November 14, 2012

    Report

    Report Number
    1045510-2012-00035
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    HILL-ROM CHARLESTON
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM REC'D A COMPLAINT ON ONE OF ITS SILKAIR LOW AIRLOSS THERAPY MATTRESS REPLACEMENT SYSTEMS WHERE THE PT WAS ALLEGEDLY AWAKEN TO A FIRE ON THE RIGHT SIDE OF THE MATTRESS. THE PT WAS NOT INJURED DURING THE EVENT AND A HILL-ROM SERVICE TECHNICIAN WAS DISPATCHED TO THE RESIDENCE TO INVESTIGATE THE INCIDENT. THE TECHNICIAN FOUND THE MATTRESS AND AIR SUPPLY HOSE MELTED AND BURNED ALONG THE PT'S RIGHT SIDE OF THE MATTRESS BUT FOUND NO PROBLEMS OR DAMAGE TO THE CONTROL UNIT WHICH MAY HAVE CONTRIBUTED TO THE ALLEGED FIRE. THE DEVICE WAS REMOVED AND SENT TO HILL-ROM ENGINEERING TO PERFORM A ROOT CAUSE INVESTIGATION. HILL-ROM WILL PROVIDE ADD'L INFO REGARDING THIS INCIDENT IN A F/U REPORT ONCE THE ROOT CAUSE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILKAIR LOW AIRLOSS THERAPY SYSTEM BED, FLOTATION THERAPY, POWERED IOQ HILL-ROM CHARLESTON 90204

    Patients

    Seq Age Sex Outcome Treatment
    1