BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 8496138 · Received April 9, 2019

    Report

    Report Number
    2936999-2019-00263
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 2, 2020
    Manufacturer
    NELLCOR PURITAN BENNETT MEXICO SA
    Product Code
    DQA
    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 · 0

    ADDITIONAL INFO: G4, H3, H6(FDM) H3 EVALUATION SUMMARY: THE SAMPLE HAS BEEN DEEMED LOST AT THIS TIME AND IF LOCATED, THE FILE WILL BE REOPENED AT THAT TIME. WITHOUT THE PHYSICAL PRODUCT, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. POST MARKET VIGILANCE WILL CONTINUE TO MONITOR THIS CONDITION FOR FUTURE POTENTIAL ACTION. RECORDS FROM EACH MANUFACTURING LOT/SERIAL ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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
    289699 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA V-SAT 180260229H

    Patients

    Seq Age Sex Outcome Treatment
    1