BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE BED

    MDR report key: 3823342 · Received February 28, 2014

    Report

    Report Number
    1824206-2014-00681
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND BROKEN WELDS ON THE RIGHT SIDE RAIL. PER THE HILL-ROM SERVICE MANUAL THE ADVANCE SERES BED REQUIRES 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 SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE RIGHT SIDE RAIL TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE RIGHT SIDE RAIL WILL NOT LATCH. THE BED IS LOCATED IN THE BED SHOP AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125362 ADVANCE BED A/C POWERED ADJUSTABLE BED FNL HILL-ROM, INC. 1105

    Patients

    Seq Age Sex Outcome Treatment
    1