BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOSITE IVIZ PORTABLE ULTRASOUND

    MDR report key: 10200137 · Received June 25, 2020

    Report

    Report Number
    MW5095227
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    June 22, 2020
    Report Date
    June 23, 2020
    Manufacturer
    FUJI SONOSITE INC.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WENT TO SCAN PATIENT BY IV THERAPY TO PLACE A LINE, HIT THE SCAN ON OPTION ON THE ULTRASOUND AND IT CAME UP WITH ERROR CODE 08X8002008A. NEWLY INSTALLED ULTRASOUND AND TRANSDUCER PROBE THAT HAS REPLACED THREE OTHER ULTRASOUNDS THAT KEEPS GIVING THE SAME ERROR CODE. SONOSITE KEEPS SENDING OUT REPLACEMENTS OF THESE ULTRASOUNDS AND PROBE AND THEY EITHER FAIL RIGHT OUT OF THE BOX FOR THE SAME ERROR CODE OR THEY WORK FOR A WEEK AND THEN FAIL WHILE TRYING TO TREAT A PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657622 SONOSITE IVIZ PORTABLE ULTRASOUND SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN FUJI SONOSITE INC. IVIZ
    657629 SONOSITE IVIZ PORTABLE ULTRASOUND SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN FUJI SONOSITE INC. IVIZ
    657630 SONOSITE IVIZ PORTABLE ULTRASOUND SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN FUJI SONOSITE INC. IVIZ
    657631 SONOSITE IVIZ PORTABLE ULTRASOUND SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN FUJI SONOSITE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention