BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED VERSACARE FRAME

    MDR report key: 1654022 · Received April 6, 2010

    Report

    Report Number
    1824206-2010-05262
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH ADJUSTED THE RIGHT HAND CPR HANDLE ASSEMBLY 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 HEAD SECTION DRIFTS BACK DOWN WHEN HEAD IS RAISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED VERSACARE FRAME AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM RITTER P3200E000035

    Patients

    Seq Age Sex Outcome Treatment
    1