BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU BED

    MDR report key: 1171934 · Received September 19, 2008

    Report

    Report Number
    1824206-2008-03526
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLAINT REVIEW, IT WAS DETERMINED THAT THE BRAKES NOT HOLDING/WORKING COULD LEAD TO UNINTENTIONAL MOVEMENT OF THE BED, WHICH HAS THE POTENTIAL TO CAUSE SERIOUS INJURY. THE TECHNICIAN REPLACED THE WORN CASTERS IN ORDER TO RESOLVE THE PROBLEM.

    Description of Event or Problem · 1

    WHILE CONDUCTING MAINTENANCE, A TECHNICIAN DISCOVERED THAT THE BRAKES ON THIS BED WERE WORN OUT AND WOULD NOT HOLD. THE BED WAS FOUND IN STORAGE AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCU BED AC POWERED HOSPITAL BED FNL HILL-ROM RITTER P894 NA

    Patients

    Seq Age Sex Outcome Treatment
    1