BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600 CARDIAC

    MDR report key: 1141165 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24422
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYS ERROR CODE "A/D CHANNEL 1 FAILURE" AND THE SYSTEM WILL NOT BOOT. THE SYSTEM FAILED AT THE BEGINNING OF THE DAY SO NO PATIENTS WERE INJURED AND NO CASES WERE DELAYED. CASES WERE PERFORMED WITH ANOTHER C-ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 CARDIAC FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1