BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2896097 · Received December 10, 2012

    Report

    Report Number
    1720753-2012-10286
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 10, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM . THE SYSTEM OPERATES AS INTENDED. THE CUSTOMER REPORTED THE LEFT MONITOR HAD GONE INTO SLEEP MODE. THEY REBOOTED THE SYSTEM AND IT HAS BEEN WORKING AS INTENDED SINCE. THE SERVICE CALL WAS CANCELED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT DISPLAY AN IMAGE ON THE LEFT MONITOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1