BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA

    MDR report key: 3893553 · Received February 15, 2014

    Report

    Report Number
    1824206-2014-00452
    Event Type
    Malfunction
    Date Received
    February 15, 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
    NJ, 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. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWS THAT THE LAST PREVENTIVE MAINTENANCE WAS AUGUST 2013.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING PT RIGHT HEAD SIDE RAIL STUCK IN DOWN POSITION. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99591 ADVANTA AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC P1600

    Patients

    Seq Age Sex Outcome Treatment
    1