BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2800045 · Received October 17, 2012

    Report

    Report Number
    9680959-2012-01314
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 17, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE CONNECTOR WAS REPAIRED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE LEFT MONITOR WAS NOT FUNCTIONING. THE LEFT MONITOR DISPLAYS THE LIVE FLUOROSCOPY IMAGE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1