BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSONIC

    MDR report key: 8775540 · Received July 10, 2019

    Report

    Report Number
    8775540
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 21, 2019
    Report Date
    July 1, 2019
    Manufacturer
    TRANSONIC SYSTEMS INC.
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER THE ANEURYSM WAS CLIPPED, THE SURGEON ATTEMPTED TO USE THE FLOW PROBE AND IT DID NOT WORK. AFTER EXTENSIVE TROUBLESHOOTING WITH THE ACTUAL MACHINE, A NEW FLOW PROBE SUPPLY WAS OPENED AND WORKED WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571140 TRANSONIC FLOWMETER, BLOOD, CARDIOVASCULAR DPW TRANSONIC SYSTEMS INC. HQN3MB

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA