BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBGYN TRANSTAR, TRANSTAR FRAME OB/G

    MDR report key: 1691952 · Received May 3, 2010

    Report

    Report Number
    1824206-2010-06696
    Event Type
    Malfunction
    Date Received
    May 3, 2010
    Date of Event
    June 3, 2008
    Report Date
    June 3, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH FOUND THE FOOT END BRAKE LINKAGE MISSING THE BOLT AND NUT. TECH REPLACED THE BOLT AND NUT ON THE FOOT END BRAKE LINKAGE TO RESOLVE THE 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

    TECH ALLEGED THAT THE BRAKES WERE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBGYN TRANSTAR, TRANSTAR FRAME OB/G A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM RITTER P8050D3885

    Patients

    Seq Age Sex Outcome Treatment
    1