BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDX

    MDR report key: 1031986 · Received April 18, 2008

    Report

    Report Number
    2183553-2008-00020
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AUTO SUBTRACTION OF PRE-CONTRAST AND POST-CONTRAST VIBRANT BREAST STUDY, A PREVIOUS PATIENT'S IMAGES WERE SUPERIMPOSED ON THE PATIENT WHO WAS PRESENTLY BEING SCANNED. IN THIS PARTICULAR INCIDENT, THE OPERATOR DETECTED THE ISSUE, AND NO INJURY OR MISDIAGNOSIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDX LNH GE MEDICAL SYSTEMS, LLC 2226300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK