BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1083687 · Received July 28, 2008

    Report

    Report Number
    1720753-2008-24119
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 29, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WILL NOT BOOT. THE PROBLEM OCCURRED WITH PATIENT ON THE TABLE AND UNDER ANESTHESIA. THE SYSTEM WORKED AFTER REBOOT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1