BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA 850 BED

    MDR report key: 1191463 · Received September 25, 2008

    Report

    Report Number
    1824206-2008-03588
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 BRAKE MECHANISM IN ORDER TO RESOLVE THE PROBLEM.

    Description of Event or Problem · 1

    WHILE MAKING ROUNDS AT A HOSPITAL, A TECHNICIAN DISCOVERED A NOTE ON THIS BED STATING THAT BRAKES DID NOT OPERATE. THERE WAS NO PATIENT INVOLVEMENT IN THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRA 850 BED AC POWERED HOSPITAL BED FNL HILL-ROM RITTER P852 NA

    Patients

    Seq Age Sex Outcome Treatment
    1