BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1040813 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21386
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MAINFRAME WOULD NOT COMPLETELY BOOT UP, STOPS AT 20 ARROWS. CUSTOMER HAS ANOTHER C-ARM THAT THEY USED TO START AND FINISH THE CASE. ALSO, THE SYSTEM WAS NOT FLUOROING. NO PATIENTS INVOLVED, NO PATIENT INJURY TO REPORT.

    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