BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3192197 · Received June 20, 2013

    Report

    Report Number
    1720753-2013-07390
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DISPLAYED A "KV ON IN ERROR" ERROR MESSAGE. THE SYS WILL NOT OPERATE WITH THIS ERROR. THIS ERROR MAY CAUSE THE SYS TO SHUT DOWN UNCOMMANDED. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279604 9900 FLUORSOCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1