BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1031037 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20668
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 14, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SVC CONTINUED TO COMPLETE INSTALLATION. SYS OPERATES AS INTENDED. THE SVC REP VERIFIED OPERATION OF VERTICAL COLUMN.

    Description of Event or Problem · 1

    DURING A DEMONSTRATION THE SVC REP FOUND THE PS 3 POWER SUPPLY TO BE BAD. NO PT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1