BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3834509 · Received March 17, 2014

    Report

    Report Number
    1720753-2014-02410
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 14, 2014
    Report Date
    March 17, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT LOSS OF X-RAY IMAGING. THIS CAN CAUSE THE SYSTEM TO BECOME UNUSABLE, DUE TO THE INABILITY TO PRODUCE A LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157089 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1