BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 1000 W/SCALE ADVANCE FRAME

    MDR report key: 1655161 · Received April 7, 2010

    Report

    Report Number
    1824206-2010-05317
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    April 25, 2007
    Report Date
    April 25, 2007
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH SHIPPED, THE ACCOUNT, A REPLACEMENT SIDERAIL TO RESOLVE THIS ISSUE. 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 SIDERAIL WILL NOT FUNCTION, DUE TO A BROKEN WELD, RESULTING IN AN INABILITY OF THE SIDERAIL TO LATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 1000 W/SCALE ADVANCE FRAME AC POWERED HOSPITAL BED FNL HILL-ROM RITTER P1115F55

    Patients

    Seq Age Sex Outcome Treatment
    1