BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2231990 · Received September 1, 2011

    Report

    Report Number
    9680959-2011-09009
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    December 22, 2009
    Report Date
    September 1, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE X-RAY TUBE. SYSTEM OPERATES AS INTENDED. THIS REPORT IS ONE OF 4607 RECORDS WITH THE PRODUCT CODE OF JAA BEING REPORTED IN RETROSPECTIVE SUMMARY REPORT (B)(4). THIS REPORT IS ONE OF 8 RECORDS WITH A "UNCOMMANDED X-RAYS" MALFUNCTION BEING REPORTED IN RETROSPECTIVE SUMMARY REPORT (B)(4). THIS REPORT IS ONE OF 8037 BEING REPORTED IN RETROSPECTIVE SUMMARY REPORT (B)(4). THESE RECORDS ARE BEING REPORTED LATE AS A RESULT OF A RETROSPECTIVE REVIEW OF THE QUALITY SYSTEM. THE MAJORITY OF THESE REPORTS INDICATES PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM PRODUCED UNCOMMANDED X-RAY. NO PATIENT OR USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 JAA JAA GE OEC MEDICAL SYSTEMS (SLC) 7700

    Patients

    Seq Age Sex Outcome Treatment
    1