BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 1070994 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-20571
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 10, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM NEEDS TO HAVE KVP OUTPUT VERIFIED PER PHYSICIST INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEM INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1