BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2182698 · Received July 8, 2011

    Report

    Report Number
    9680959-2011-01553
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 8, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THERE WAS A "GRABBER" ERROR MESSAGE AND A PART NEEDS TO BE REPLACED, HOWEVER THE SYS IS WORKING AS INTENDED AND WAS PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS INTERMITTENTLY WOULD NOT CAPTURE FLUOROSCOPIC X-RAYS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1