BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3980016 · Received June 5, 2014

    Report

    Report Number
    1720753-2014-04723
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DRIVE WAS REPLACED BY THE CUSTOMER. THE FE RELOADED SOFTWARE AND CALIBRATION FILES. THE SYSTEM NODES WERE REFLASHED. THE SYSTEM BOOTED UP WITH AN ERROR FOLLOWING REPAIR. THE CUSTOMER DECIDED TO FIX THE ERROR ON THEIR OWN. NO CONCLUSION CAN BE DRAWN AS FINAL REPAIR INFORMATION IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT MAKE X-RAYS. THIS RESULTED A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY ORE DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330328 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1