BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 3000 W/SCALE, ADVANCE FRAME

    MDR report key: 1665999 · Received April 16, 2010

    Report

    Report Number
    1824206-2010-04095
    Event Type
    Malfunction
    Date Received
    April 16, 2010
    Date of Event
    January 7, 2008
    Report Date
    January 7, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT FOUND LOOSE CONNECTIONS INSIDE THE FOOT PANEL, ACCOUNT TIGHTENED THE CONNECTIONS AND ISSUE IS 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

    ACCOUNT ALLEGED THE BED HAS A LOSS OF GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 3000 W/SCALE, ADVANCE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM RITTER P1165F55

    Patients

    Seq Age Sex Outcome Treatment
    1