BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2833602 · Received October 29, 2012

    Report

    Report Number
    1720753-2012-08791
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 29, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYS WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR MAY RESULT IN A SYSTEM LOCK UP OR SHUT DOWN DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1