BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE PULMONARY SURFACE TOTAL CARE FRAME

    MDR report key: 1483647 · Received July 28, 2009

    Report

    Report Number
    1824206-2009-03921
    Event Type
    Malfunction
    Date Received
    July 28, 2009
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN REPLACED (GCI) & LEFT (UCM) CABLE TO RESOLVE THE ISSUE. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Description of Event or Problem · 1

    (GCI) FUNCTIONS VERY ERRATIC, LEFT (UCM) CABLE CUT - WIRES EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE PULMONARY SURFACE TOTAL CARE FRAME AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM RITTER P1900H006263

    Patients

    Seq Age Sex Outcome Treatment
    1