BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 961865 · Received May 9, 2007

    Report

    Report Number
    1720753-2007-00616
    Event Type
    Malfunction
    Date Received
    May 9, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 9, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REPRESENTATIVE INVESTIGATED AND COULD NOT DUPLICATE THE MALFUNCTION NOTED. THERE WAS A NOTED ERROR IN THE SYSTEM LOG THAT INDICATED A SYSTEM REQUEST FOR 120 KV AND THE SYSTEM RECEIVED 0KV AN THIS MAY HAVE CAUSED THE APPARENT LOCK-UP. THE ISSUE DID NOT OCCUR. THE INTERCONNECT CABLE WAS SUGGESTED FOR REPLACEMENT AND THE IN-HOUSE ENGINEER WAS GOING TO ORDER AND INSTALL. THE SYSTEM WAS RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WOULD NOT RELEASE ANY PATIENT INFORMATION WITH RESPECT TO THIS MALFUNCTION. NO PATIENT HARM OCCURRED.

    Description of Event or Problem · 1

    THE GE OEC 9800 FLUOROSCOPY SYSTEM HAD AN OCCURRANCE OF A LEFT MONITOR THAT WENT BLANK DURING A PROCEDURE AND INITALLY WOULD NOT REBOOT TO CORRECT THE MALFUNCTION. THIS ISSUE COULD NOT BE DUPLICATED AND OCCURRED ONLY ONE TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *