BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3802122 · Received December 30, 2013

    Report

    Report Number
    1720753-2013-13866
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 11, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE 5VDC POWER SUPPLY WAS EVALUATED AND CALIBRATED TO THE OPTIMAL OPERATING VOLTAGE. THE INTERCONNECT CABLE WAS ALSO REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR IS LIKELY TO RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679790 9800 FUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1