BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 8505786 · Received April 11, 2019

    Report

    Report Number
    1282497-2019-00017
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 11, 2019
    Manufacturer
    NELLCOR PURITAN BENNETT MEXICO SA
    Product Code
    DQA
    UDI-DI
    10884522042468
    PMA / PMN Number
    K162014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CAUSED AN ULCER TONGUE LACERATION TO AN ANIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299272 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA V-SAT 180260229H 10884522042468

    Patients

    Seq Age Sex Outcome Treatment
    1