BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SDU-450XL

    MDR report key: 2803909 · Received September 20, 2012

    Report

    Report Number
    2803909
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    April 26, 2012
    Report Date
    September 20, 2012
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    HEM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS REVIEWING NUMEROUS SCANS FROM THE PREVIOUS DAY AND COMPLAINED THAT THE QUALITY OF THE IMAGES WERE OF NOT AS CLEAR AS HE WOULD LIKE. THERE WERE NO CHANGES TO THE PATIENTS' PLAN OF CARE. TESTING CONTINUED AT NORMAL INTERVALS. THE TESTS WERE DONE BY THE SAME PHYSICIAN AND THE PHYSICIAN IS VERY EXPERIENCED. A COMMONALITY BETWEEN ALL INVOLVED PATIENTS IS OBESITY--PATIENTS WERE PREGNANT. OUTSIDE OF THIS REPORT, WE HAVE NOT HAD A TREND WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SDU-450XL SYSTEM, ULTRASOUND HEM SHIMADZU MEDICAL SYSTEMS SDU-450XL *

    Patients

    Seq Age Sex Outcome Treatment
    1 *