BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE

    MDR report key: 1082127 · Received July 25, 2008

    Report

    Report Number
    1824206-2008-02890
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    January 20, 2006
    Report Date
    January 20, 2006
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WHICH WAS PLACED IN THIS BED WEIGHT IS SMALLER THAN THE INTENDED USE OF THE PROD. THE TECH COULD FIND NO PROBLEMS WITH THE BED, AND FOUND THAT THE BED OPERATED WITHIN SPECS.

    Description of Event or Problem · 1

    A NURSE ALLEGED, SHE FOUND A PT'S WRIST ENTRAPPED BETWEEN THE UNDER SIDE OF THE RIGHT HEAD SIDERAIL AND THE MATTRESS. THE NURSE REPORTED THAT THE BED WAS IN THE LOW POSITION AND THE SLEEP SURFACE WAS FLAT WHEN THE ENTRAPMENT OCCURRED. THE NURSE REPORTED THAT THE PT WAS NOT INJURED DUE TO THE ENTRAPMENT.

    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