BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3962728 · Received June 23, 2014

    Report

    Report Number
    1720753-2014-05287
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SYSTEM HAD PRECHARGE VOLTAGE ERRORS AND WOULD NOT DELIVER X-RAYS. THIS ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING, WHICH WOULD RESULT IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364617 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1