BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 1141363 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24496
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERROR CODE DISPLAYED. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED ERROR CODES 430 AND 431. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1