BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBGYN TRANSTAR, TRANSTAR FRAME OB/G

    MDR report key: 1689523 · Received May 10, 2010

    Report

    Report Number
    1824206-2010-07066
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    May 11, 2007
    Report Date
    May 11, 2007
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH REPLACED THE ROCKER ARM AND BRAKE MECHANISM 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 ROCKER ARM ON THE BRAKE MECHANISM DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBGYN TRANSTAR, TRANSTAR FRAME OB/G WHEELED STRETCHER FPO HILL-ROM, INC. P8050D000634

    Patients

    Seq Age Sex Outcome Treatment
    1