BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCE 2000 W/ SCALE ADVANCE FRAME

    MDR report key: 1714370 · Received June 3, 2010

    Report

    Report Number
    1824206-2010-07878
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    August 31, 2007
    Report Date
    August 31, 2007
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN CHECKED THE BED EXIT AND FOUND THAT THE BED EXIT FUNCTIONED PROPERLY. TECHNICIAN DID FIND THAT THERE WERE PINS BENT ON THE CORBEL COMMUNICATION CABLE BUT THE BED EXIT STILL RANG THE NURSE CALL SYSTEM WHEN THE BED EXIT ALARMED. 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

    ACCOUNT ALLEGED THAT THE PT WAS FOUND ON THE FLOOR NEXT TO THE BED. THE PT WAS NOT INJURED DUE TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 2000 W/ SCALE ADVANCE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P1145F55

    Patients

    Seq Age Sex Outcome Treatment
    1 Other