BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOPPLER MODEL 812

    MDR report key: 22902318 · Received August 27, 2025

    Report

    Report Number
    22902318
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    January 19, 2025
    Report Date
    August 21, 2025
    Manufacturer
    PARKS MEDICAL ELECTRONICS, INC.
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY, THE DOPPLERS AND PROBES USED IN THE OPERATING ROOM WERE FOUND TO BE FAULTY. DESPITE PLACING THE PROBE DIRECTLY ON TOP OF THE BLOOD VESSEL, THE EQUIPMENT FAILED TO FUNCTION PROPERLY. MULTIPLE ATTEMPTS WERE MADE, INVOLVING THREE DIFFERENT PROBES AND THREE DIFFERENT DOPPLER BOXES, TO FIND A WORKING COMBINATION. EVEN WHEN A FUNCTIONAL COMBINATION WAS FOUND, THE RESULTS WERE BARELY ACCEPTABLE. BATTERY DEPLETION WAS RULED OUT AS ALL THREE BOXES WERE FULLY CHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251137 DOPPLER MODEL 812 FLOWMETER, BLOOD, CARDIOVASCULAR DPW PARKS MEDICAL ELECTRONICS, INC. 812-1

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male