BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2041000 · Received March 23, 2011

    Report

    Report Number
    9680959-2011-00851
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM'S MONOBLOCK REQUIRED REPLACEMENT. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1