BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOUND F75

    MDR report key: 7297183 · Received February 26, 2018

    Report

    Report Number
    7297183
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 9, 2018
    Manufacturer
    HITACHI HEALTHCARE AMERICAS
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR OUTPATIENT ENDOSCOPIC ULTRASOUND WITH ANESTHESIA AND CYTOLOGY. PROCEDURE STARTED, AND A WHITE RING/HALO NOTED ON ULTRASOUND SCREEN WITH THE RADIAL SCOPE, UNABLE TO SEE PROPER ULTRASOUND IMAGE. OLYMPUS REPRESENTATIVE ON THE PHONE AFTER WE SWITCHED SCOPES TO THE LINEAR ULTRASOUND SCOPE. STILL WITH SAME HALO IMAGE ON THE MONITOR. REPRESENTATIVE ATTEMPTED TROUBLESHOOTING WITH US OVER THE PHONE, BUT WE WERE UNABLE TO REMEDY THE SITUATION. BIOMED WAS THEN CALLED AND ASKED TO COME EMERGENTLY AS WE HAD A SEDATED PATIENT ON THE TABLE AND NEEDED HELP TO FIX THE MACHINE. PROCEDURE THEN ABORTED, PATIENT NEEDS TO RESCHEDULE. ENDOSCOPIC ULTRASOUND BOOKED FOR TOMORROW, HAD TO BE CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141423 PROSOUND F75 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN HITACHI HEALTHCARE AMERICAS 1PF-1907

    Patients

    Seq Age Sex Outcome Treatment
    1