BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4142570 · Received September 26, 2014

    Report

    Report Number
    1720753-2014-08227
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 26, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DISK DRIVE WAS EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED. 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 "FILES CORRUPTION" ERROR MESSAGE UPON BOOT. THIS ERROR PREVENTED THE SYSTEM FROM BOOTING TO A USABLE STATE. 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
    600574 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1