BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE

    MDR report key: 3893510 · Received February 14, 2014

    Report

    Report Number
    1824206-2014-00441
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE CAUSE OF THE SIDE RAIL NOT LATCHING WAS A BENT SLIDE BRACKET. THE BRACKET WAS REPLACED AND THE BED FUNCTIONED AS EXPECTED. THE MOST PROBABLE CAUSE FOR THE BENT SLIDE BRACKET IS MECHANICAL DAMAGE. NO FURTHER ACTION REQUIRED. PER THE HILL-ROM SERVICE MANUAL THE ADVANCE SERIES 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 SHOWS THAT THE LAST PREVENTIVE MAINTENANCE WAS (B)(4) 2013.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING UNABLE TO RAISE SIDE RAIL. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99192 ADVANCE A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1105

    Patients

    Seq Age Sex Outcome Treatment
    1