BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA BED

    MDR report key: 1960083 · Received December 17, 2010

    Report

    Report Number
    1824206-2010-11732
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH INSPECTED THE BED AND FOUND THE BRAKE PEDAL ENGAGES WHEN FIRMLY PRESSED DOWN, BUT IF YOU PUSH THE BRAKE PEDAL AT ONE END OF THE BED, IT DOES NOT FULLY ENGAGE THE BRAKE PEDAL AT THE OPPOSITE SIDE OF THE BED. HE ALSO FOUND THE HOLES IN THE FRAME WHERE THE CROSS SHAFTS GO THROUGH LOOK OBLONG, ALLOWING TOO MUCH PLAY IN THE LINKAGE. THE TECHNICIAN REPLACED THE CASTERS AND USED WASHERS TO REMOVE THE PLAY IN THE LINKAGE, BUT THE ISSUE REMAINS. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE NURSING STAFF WAS PREPARING TO MOVE A PT OUT OF BED. THE PT WAS COMBATIVE AND THE NURSE STATED THE BRAKE DISENGAGED, CAUSING THE BED TO MOVE TOWARDS HER AND INJURING HER KNEE. THE NURSE WAS TREATED WITH A KNEE ACE BANDAGE AND GIVEN IBUPROFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK