BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBGYN TRANSTAR TRANSTAR FRAME OB/G

    MDR report key: 1572437 · Received December 21, 2009

    Report

    Report Number
    1824206-2009-07756
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Date of Event
    October 17, 2007
    Report Date
    October 17, 2007
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN TIGHTENED THE BRAKE PAD ON THE CASTER 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

    TECHNICIAN ALLEGED THAT THE STRETCHER HAD A CASTER ON THE LEFT FOOT THAT THE BRAKE WAS NOT HOLDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBGYN TRANSTAR TRANSTAR FRAME OB/G WHEELED STRETCHER FPO HILL-ROM RITTER P8050D3844

    Patients

    Seq Age Sex Outcome Treatment
    1