BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3192246 · Received June 20, 2013

    Report

    Report Number
    1720753-2013-07388
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CONNECTORS WERE RESEATED DURING THE SVC CALL. 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 WAS STUCK IN SUBTRACTION MODE AND WERE UNABLE TO REBOOT. THIS ISSUE MAY REFER TO A LOSS OF SYS FUNCTIONALITY. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281534 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1