BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC 9600

    MDR report key: 1173036 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26046
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPLACED THE HARD DRIVE. HE REPLACED DISK CONTROLLER PCB, DUE TO NEW REVISION OF HARD DRIVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE WORKSTATION KEEPS REBOOTING ITSELF. THE PROBLEM OCCURS AFTER INITIAL POWER ON OF SYSTEM. NO PATIENT WAS INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1