BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2231996 · Received September 1, 2011

    Report

    Report Number
    1720753-2011-11817
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    May 20, 2008
    Report Date
    September 1, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HARD DRIVE. SYSTEM OPERATES AS INTENDED. THIS REPORT IS ONE OF (B)(4) RECORDS WITH THE PRODUCT CODE OF IZL BEING REPORTED IN RETROSPECTIVE SUMMARY REPORT (B)(4). THIS REPORT IS ONE OF 6 RECORDS WITH A "DATA MIX" MALFUNCTION BEING REPORTED IN RETROSPECTIVE SUMMARY REPORT (B)(4). THIS REPORT IS ONE OF (B)(4) 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 INDICATE PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM MIXED UP IMAGES. NO PATIENT OR USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 IZL IZL GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1