BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1930016 · Received December 2, 2010

    Report

    Report Number
    9680959-2010-00554
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    August 17, 2010
    Report Date
    November 30, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE CONTACTED THE CUSTOMER AND WAS ABLE TO FIX THE PROBLEM OVER THE PHONE. NO GE SERVICE WAS NEEDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE NEW SYSTEM DOSAGE OUTPUT IS TWICE THE DOSAGE OF THE OLD SYSTEM. NO PATIENT 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