BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3124035 · Received May 17, 2013

    Report

    Report Number
    9680959-2013-00990
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE. THE CUSTOMER DECLINED REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYS WOULD NOT DISPLAY AN IMAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219591 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1