BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3063549 · Received April 12, 2013

    Report

    Report Number
    1720753-2013-04933
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    October 16, 2012
    Report Date
    April 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INTERMITTENTLY THERE WAS NO IMAGE ON THE SCREEN. THE FIELD ENGINEER NOTED THAT THERE WAS AN INTERMITTENT LOSS OF THE LIVE IMAGE, THUS MAKING THE SYSTEM UNUSABLE. 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
    157839 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1