BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA

    MDR report key: 3893535 · Received February 14, 2014

    Report

    Report Number
    1824206-2014-00442
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 17, 2014
    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

    HILL-ROM SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE WELDING ON THE SIDE RAIL ARM HAD BROKEN. THE TECHNICIAN REPLACED THE SIDE RAIL. THE MOST PROBABLE CAUSE FOR THE SIDE RAIL ARM TO BREAK IS MECHANICAL DAMAGE. NO FURTHER ACTION IS REQUIRED. PER THE HILL-ROM SERVICE MANUAL THE ADVANTA BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE SIDE RAIL FOR PROPER LATCHING. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWS THAT THE LAST PREVENTIVE MAINTENANCE WAS PERFORMED NOVEMBER 2011.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A USER FACILITY STATING RIGHT HEAD SIDE RAIL IS BROKEN AND WILL NOT LATCH IN THE UP POSITION. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99064 ADVANTA A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1600

    Patients

    Seq Age Sex Outcome Treatment
    1