BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3862907 · Received February 20, 2014

    Report

    Report Number
    1720753-2014-01698
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE GIB PCB WAS EVALUATED AND RESEATED. 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 ERROR MESSAGE. THIS ERROR MAY LIKELY TO RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN SITUATION ON WHEN THE LOSS OF COMMUNICATION OCCURRED. THERE IS NO PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106777 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1