BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA BED

    MDR report key: 3893523 · Received February 15, 2014

    Report

    Report Number
    1824206-2014-00458
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE CASTERS WERE WORN. NORMAL WEAR ON MECHANICAL PARTS IS ANTICIPATED AND INSPECTION OF THESE PARTS IS INCLUDED IN THE PREVENTATIVE MAINTENANCE SCHEDULE TO INSURE PROPER OPERATION. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWS HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2009-2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN CALIBRATED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE BRAKES WOULD NOT HOLD IN BRAKE MODE. THE BED WAS LOCATED IN THE REPAIR AREA. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99712 CENTRA BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P850

    Patients

    Seq Age Sex Outcome Treatment
    1