BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 3000 SERIES

    MDR report key: 1872597 · Received September 28, 2010

    Report

    Report Number
    1872597
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 28, 2010
    Manufacturer
    HILL-ROM
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MAINTENANCE ACTIVITIES REVEALED A TREND OF FAILURE, WITH INCREASING FREQUENCY THAT IS TAKING PLACE WITH THIS BED. THE STEERING WHEEL WHICH IS ATTACHED TO THE FRAME HAS BEEN FAILING; THIS IS DUE TO STRESS AT THE WELD THAT ATTACHES THE WHEEL TO THE FRAME. THE STRESS FRACTURE IN THE WELD CAUSES THE WHEEL TO FAIL AND SHEER OFF OF THE FRAME. THIS POSES A SAFETY RISK, AS TIPPING COULD RESULT IN A FALL, OR CAUSE A PATIENT TO BECOME WEDGED BETWEEN THE SIDE RAIL AND BED IF THE FAILURE WERE TO OCCUR WHILE OCCUPIED. THERE HAVE BEEN A TOTAL OF 6 FAILURES, ALL REQUIRING THE MAIN FRAME OF THE BED TO BE REPLACED OR THE BED BE REMOVED FROM SERVICE INDEFINITELY. THIS YEAR WE HAVE HAD THREE (3) FAILURES WITH TWO (2) TAKING PLACE WITHIN THE LAST MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 3000 SERIES HOSPITAL ELECTRIC BEDS FNL HILL-ROM N1165F59 *
    2 ADVANCE 3000 SERIES HOSPITAL ELECTRIC BEDS FNL HILL-ROM N1165F59 *
    3 ADVANCE 3000 SERIES HOSPITAL ELECTRIC BEDS FNL HILL-ROM N1165F59 *
    4 ADVANCE 3000 SERIES HOSPITAL ELECTRIC BEDS FNL HILL-ROM N1165F59 *
    5 ADVANCE 3000 SERIES HOSPITAL ELECTRIC BEDS FNL HILL-ROM N1165F59 *
    6 ADVANCE 3000 SERIES HOSPITAL ELECTRIC BEDS FNL HILL-ROM N1165F59 *
    7 ADVANCE 3000 SERIES HOSPITAL ELECTRIC BEDS FNL HILL-ROM N1165F59 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES