BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOPPLER PENCIL PROBE

    MDR report key: 4608325 · Received March 3, 2015

    Report

    Report Number
    4608325
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Date of Event
    February 25, 2015
    Report Date
    March 3, 2015
    Manufacturer
    PARKS MEDICAL ELECTRONICS, INC
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN FOR RIGHT FEMORAL TO PERONEAL BYPASS. DOPPLER PROBE USED TO CHECK PULSES ON OPERATIVE FIELD WITHOUT INCIDENT PRIOR TO BYPASS GRAFTING. BYPASS ANASTOMOSIS COMPLETED, PULSE CHECKED WITH DOPPLER PROBE WITH POOR AUDIBLE PULSE. A SECOND DOPPLER PROBE WAS USED AND PULSES WITH EXCELLENT AUDIBLE PULSE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145457 DOPPLER PENCIL PROBE PENCIL PROBE, PULSED DOPPLER, ULTRASONIC IYN PARKS MEDICAL ELECTRONICS, INC 832-1950-11 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR