BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 1905674 · Received November 12, 2010

    Report

    Report Number
    1824206-2010-11003
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED AND FOUND THAT WITH NO ONE IN THE BED, THE SCALE WAS READING (B)(6). ONCE THE TECHNICIAN ZEROED THE SCALE, HE WAS ABLE TO TEST BED EXIT AND THE BED EXIT AND AIR SYSTEM WORKED PROPERLY. THE TECHNICIAN INDICATED THAT IT APPEARS THAT ANY ISSUE WITH THE BED WOULD HAVE BEEN CAUSED BY IMPROPER SCALE USAGE BY THE NURSING STAFF. THE ACCOUNT WOULD NOT RELEASE ANY INFO REGARDING THE EVENT.

    Description of Event or Problem · 1

    THE NURSE MANAGER ALLEGED A FALL WITH THE PT SITTING ON THE EDGE OF THE BED. WHILE THE PT WAS URINATING INTO A URINE BOTTLE, SITTING ON SIDE OF BED, HE FELL OUT AND HIT HIS HEAD LEAVING A KNOT. THE PT ALLEGED THE MATTRESS PUSHED HIM OUT OF THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK