BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE-TREAT SURFACE&SCALE TOTAL CARE FRAME

    MDR report key: 1708596 · Received August 20, 2009

    Report

    Report Number
    1824206-2009-04770
    Event Type
    Malfunction
    Date Received
    August 20, 2009
    Date of Event
    October 18, 2006
    Report Date
    October 18, 2006
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN USED SIDECOM TESTER AND FOUND SIDECOM PC BOARD BAD. TECH REPLACED BOARD AND PERFORMED OPERATION CHECK. ALL PASS. 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

    BED NOT SENDING NURSE CALL OUT TO STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE-TREAT SURFACE&SCALE TOTAL CARE FRAME AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM RITTER P1900AF1619

    Patients

    Seq Age Sex Outcome Treatment
    1