BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHIMADZU DAR-8000F

    MDR report key: 3159252 · Received March 6, 2013

    Report

    Report Number
    8030233-2013-00001
    Event Type
    Other
    Date Received
    March 6, 2013
    Manufacturer
    SHIMADZU CORP.
    Product Code
    IZI
    PMA / PMN Number
    K052500
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    WE ALREADY CONTACTED WITH THE USER FACILITY. THE REPEATABILITY OF INCIDENT IS NOT SO HEIGHT. THE FIELD SERVICE ENGINEER INVESTIGATED THE DEVICE ON SITE, AND REPLACED SOME ELECTRICAL PARTS. WE ARE STILL FOLLOWING THEM, AND COULD NOT DECIDE THE FINAL CONCLUSION FOR THIS INCIDENT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96696 SHIMADZU DAR-8000F SYSTEM, X-RAY, ANGIOGRAPHIC IZI SHIMADZU CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1