BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3241043 · Received July 18, 2013

    Report

    Report Number
    9680959-2013-01429
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT. AS OF THIS DATE, THIS RECORD IS AWAITING ADDITIONAL INFO. HOWEVER, THIS ISSUE IS DESCRIPTIVE OF A COMPLETE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336426 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1