BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 8024785 · Received October 31, 2018

    Report

    Report Number
    9610849-2018-00047
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Report Date
    October 31, 2018
    Manufacturer
    NELLCOR PURITAN BENNETT MEXICO SA
    Product Code
    DQA
    PMA / PMN Number
    K162014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WAS USED ON PATIENT AND PATIENT¿S TONGUE GOT SWOLLEN. IT WAS STATED THAT THE DEVICE WAS TESTED AND THE AVERAGE TEMPERATURE WAS AROUND 75.2 DEGREES FAHRENHEIT. IT WAS REPORTED THAT THE ISSUE WAS CAUSED BY PRESSURE AND THERE WERE FLUIDS AROUND THE ANIMAL TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864035 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA V-SAT 1735204H

    Patients

    Seq Age Sex Outcome Treatment
    1