BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1221546 · Received November 5, 2008

    Report

    Report Number
    9680959-2008-00214
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 5, 2008
    Manufacturer
    GE OCE MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP EVALUATED THE SYSTEM AND DETERMINED THAT THE MONOBLOCK NEEDED REPLACEMENT. THE CUSTOMER ORDERED A PART FROM THE PART SOURCE. GE/OEC SHOWED UP AT THE FACILITY AND THE CUSTOMER REQUESTED ASSISTANCE WITH THE INSTALLATION. THEY REPLACED THE MONOBLOCK. THE SYSTEM IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO X-RAY PRODUCED DURING A PROCEDURE. NO PT HARM WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1