BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE

    MDR report key: 1082121 · Received July 25, 2008

    Report

    Report Number
    1824206-2008-02896
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    December 5, 2005
    Report Date
    December 5, 2005
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLAINT REVIEW IT WAS DETERMINED THAT THIS TYPE OF SELF ACTIVATION HAS THE POTENTIAL TO CAUSE SERIOUS INJURY AND IS THEREFORE BEING REPORTED LATE. THE TECHNICIAN COULD FIND NO PROBLEMS WITH THE BED OR MATTRESS AND EVERYTHING OPERATED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THIS BED'S TURN ASSIST FEATURE SELF ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE AC POWERED HOSPITAL BED FNL HILL-ROM RITTER P3200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1