BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3101685 · Received April 30, 2013

    Report

    Report Number
    1720753-2013-05483
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE BOARD WAS REPLACED, THE PS1 POWER SUPPLY VOLTAGE WAS ADJUSTED, THE SYSTEM SOFTWARE WAS RELOADED AND THE SYSTEM INTERFACE CABLES WERE RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED COMMUNICATION ERROR MESSAGES. THIS ERROR MESSAGE WILL LIKELY CAUSE THE SYSTEM TO LOCK-UP OR SHUT DOWN OR PREVENT THE SYSTEM FROM BOOTING UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187705 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1