BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 8963593 · Received September 5, 2019

    Report

    Report Number
    2936999-2019-00682
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    September 5, 2019
    Manufacturer
    NELLCOR PURITAN BENNETTE MEXICO SA
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 UNIT WAS GIVING LOW SPO2 READINGS. SENSORS WERE INTERMITTENTLY UNRESPONSIVE. THERE WAS NO ANIMAL HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757390 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETTE MEXICO SA V-SAT 181660254H

    Patients

    Seq Age Sex Outcome Treatment
    1