BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1070845 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-22800
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACTION: RETURNED BREAKER TO NORMAL POSITION. TESTED SYSTEM. SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO BOOT-UP OR POWER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1