BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20MHZ MICRO DISPOSABLE DOPPLER PROBE

    MDR report key: 12851877 · Received November 19, 2021

    Report

    Report Number
    MW5105479
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    November 17, 2021
    Report Date
    November 17, 2021
    Manufacturer
    MIZUHO MEDICAL INNOVATION / VASCULAR TECHNOLOGY INCORPORATED
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MIZUHO 20 MHZ MICRO DISPOSABLE DOPPLER PROBE WOULD NOT WORK. REPLACED WITH "LIKE" DEVICE THAT FUNCTIONED WITHOUT ISSUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739106 20MHZ MICRO DISPOSABLE DOPPLER PROBE FLOWMETER, BLOOD, CARDIOVASCULAR DPW MIZUHO MEDICAL INNOVATION / VASCULAR TECHNOLOGY INCORPORATED 07-150-12 (10)17128

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female