BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM DEFINITION

    MDR report key: 1191366 · Received September 26, 2008

    Report

    Report Number
    2240869-2008-00021
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    July 24, 2008
    Report Date
    September 22, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    JAK
    PMA / PMN Number
    K052216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURED IN OTHER COUNTRY. THE REPORTED ISSUE WAS CONFIRMED BY THE FACTOR AND A CORRECTIVE ACTION IS SCHEDULED TO BE RELEASED BY THE END OF 2008.

    Description of Event or Problem · 1

    A DR REPORTS AN IMAGE LEFT/RIGHT ORIENTATION MISMATCH DURING A PRONE STUDY. THE IMAGES ARE MADE AND SAVED CORRECTLY BY THE SYSTEM. BUT IF THE CORRECT IMAGES ARE OPENED IN ANOTHER SIEMENS IMAGE APPLICATION, THE LEFT/RIGHT ORIENTATION IS REVERSED 180 DEGREES. THERE IS NO INJURY OR DEATH ASSOCIATED WITH THIS REPORTED ISSUE. THE INCIDENT OCCURRED IN OTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOMATOM DEFINITION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS MEDICAL SOLUTIONS USA, INC. 14403000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1