BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1221544 · Received November 5, 2008

    Report

    Report Number
    9680959-2008-00212
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 3, 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

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP ORDER A NEW MONO BLOCK AND WAS WAITING FOR PERSONAL FROM ANOTHER COUNTRY, TO SHOW UP AT THE END OF THE MONTH. THE SYSTEM IS OPERATIONAL AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONOBLOCK WAS INTERMITTENTLY ARCING. THE MOTOR LOCK NEEDS TO BE REPLACED TO CUSTOMER WAS STILL ABLE TO USE THE SYSTEM. NO PT INJURY TO REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1