BEUDAMED
    FDA Adverse Event Summary report: N

    VERSACARE BED WITH PRIME AIR MATTRESS

    MDR report key: 1012551 · Received January 31, 2008

    Report

    Report Number
    1012551
    Date Received
    January 31, 2008
    Report Date
    November 27, 2007
    Manufacturer
    HILL-ROM COMPANY, INC.
    Product Code
    FNL
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BED SCALE AND BED ALARM ARE COORDINATED. STAFF MEMBERS UNFAMILIAR WITH HOW THE BED OPERATES, INADVERTENTLY "ZERO" THE BED BY RANDOMLY PUSHING BUTTONS. WHEN THIS HAPPENS THE BED ALARM CANNOT BE REACTIVATED UNTIL THE PATIENT IS REMOVED FROM THE BED AND THE SCALE IS AGAIN "ZEROED" OUT. THEREFORE, THOSE PATIENT'S AT RISK FOR FALLING OUT OF BED DO NOT HAVE THE BED ALARM PROTECTION. THE FACILITY TESTED THE BEDS AND DISCUSSED THIS WITH THE VENDOR. ADDITIONAL TRAINING WAS PROVIDED TO THE NURSING STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACARE BED WITH PRIME AIR MATTRESS BED, HOSPITAL FNL HILL-ROM COMPANY, INC. #455 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *