BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 10254030 · Received July 9, 2020

    Report

    Report Number
    2936999-2020-00477
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    February 7, 2020
    Report Date
    July 9, 2020
    Manufacturer
    NELLCOR PURITAN BENNETT MEXICO SA
    Product Code
    DQA
    PMA / PMN Number
    K162014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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, DURING THE OPERATION WITH SPO2 MEASUREMENT, WHITE BURN-LIKE EROSION WAS PRODUCED AT THE SENSOR SITE. DURING THE OPERATION, THE SENSOR STAYED PUT AT THE SAME SITE ON THE TONGUE FOR 15 MINUTES WITHOUT CHANGING THE SITE BUT THE DOCTOR SWADDLED THE TONGUE WITH A WATER-WETTED GAUZE BEFORE PLACING SENSOR. ALSO A SHEET TO BLOCK OUT LIGHT WAS COVERING THE SENSOR SITE DURING THE SPO2 MEASUREMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714746 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA V-SAT 171490102H

    Patients

    Seq Age Sex Outcome Treatment
    1