BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION 500D

    MDR report key: 1191106 · Received September 26, 2008

    Report

    Report Number
    2126677-2008-00075
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC.
    Product Code
    JAA
    PMA / PMN Number
    K081091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION BY THE GE FIELD ENGINEER REVEALED THAT THE MONITOR PLATE WAS NOT ADEQUATELY INSTALLED TO SUPPORT THE WEIGHT OF THE MONITOR. THE MONITOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRECISION 500D MONITOR FELL OFF OF THE WALL. THE APPROXIMATE WEIGHT OF THE MONITOR AND SUSPENSION IS 24LBS. THE CONCERN IS THAT A SERIOUS INJURY MAY RESULT IF THE MONITOR WERE TO FALL AND CONTACT AN OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION 500D JAA GE MEDICAL SYSTEMS, LLC. 2236709 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA