BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE SPORT BED

    MDR report key: 2033901 · Received March 23, 2011

    Report

    Report Number
    1824206-2011-01810
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 9, 2008
    Report Date
    January 9, 2008
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT THE HYDRAULIC FLUID KEEPS BUILDING UP BEHIND THE HEAD HI LOW VALVE, BYPASSING THE RUBBER O-RING DESIGNED TO STOP THE HYDRAULIC FLUID. THE TECHNICIAN REPLACED THE HEAD HI LOW VALVE TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE HEAD OF THE BED WILL NOT RISE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE SPORT BED AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1