BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 1000

    MDR report key: 1813139 · Received August 18, 2010

    Report

    Report Number
    1824206-2010-09390
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 TECHNICIAN ALLEGED THE CASTER TUBE BROKE LOOSE FROM BASE FRAME FROM A DEFECTIVE WELD. HE REPLACED THE BASE FRAME TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 1000 AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1105F52

    Patients

    Seq Age Sex Outcome Treatment
    1