BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 2000 W/SCALE ADVANCE FRAME

    MDR report key: 1780141 · Received May 6, 2010

    Report

    Report Number
    1824206-2010-06939
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    January 25, 2007
    Report Date
    January 25, 2007
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS REPORT, HILL-ROM HAS YET TO RECEIVE ANY CORRESPONDENCE REGARDING RESOLUTION TO THIS COMPLAINT. THEREFORE HILL-ROM IS UNABLE DETERMINE WHETHER OR NOT THIS ISSUE HAS BEEN RESOLVED. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT THE BASE FRAME IS BROKEN NEAR THE CASTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 2000 W/SCALE ADVANCE FRAME A/C POWERED HOSPITAL BED FNL HILL-ROM, INC. P1145E59

    Patients

    Seq Age Sex Outcome Treatment
    1