BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3860990 · Received April 14, 2014

    Report

    Report Number
    9680959-2014-00509
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE IPC WAS EVALUATED AND REPLACED. THE COLLIMATOR WAS RECALIBRATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXPERIENCED AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND AN UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228468 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1