BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3963417 · Received May 30, 2014

    Report

    Report Number
    1720753-2014-04572
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 30, 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

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM FAILED TO GENERATE FLUOROSCOPY X-RAY. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319804 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1