BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY AIR ELITE BLOWER

    MDR report key: 2231564 · Received August 24, 2011

    Report

    Report Number
    1045510-2011-00032
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CAREMED SUPPLY INC
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT A PT FELL OUT OF BED. AS A RESULT, THE PT FRACTURED THEIR HIP. A HILL-ROM TECH INSPECTED THE SYNERGY AIR SURFACE AND FOUND IT TO BE WORKING PROPERLY. THE PT WAS ON A FRAME THAT IS DISTRIBUTED BY HILL-ROM. THE AIR SURFACE THAT THE PT WAS ON IS ALSO DISTRIBUTED BY HILL-ROM, BUT HILL-ROM IS THE INITIAL IMPORTER OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY AIR ELITE BLOWER BED, FLOTATION THERAPY, POWERED FNM CAREMED SUPPLY INC 6881 SAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention