BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 8024799 · Received October 31, 2018

    Report

    Report Number
    9610849-2018-00048
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 4, 2018
    Report Date
    March 25, 2019
    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 · 0

    THE UNIT WAS RECEIVED FOR EVALUATED. THE REPORTED EVENT COULD NOT BE DUPLICATED/CONFIRMED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE USAGE (SENSOR NOT CHECKED CONSTANTLY). BASED ON THE INVESTIGATION RESULTS WE CAN CONCLUDE THAT THE REPORTED EVENT COULD NOT BE DUPLICATED/CONFIRMED, THE SAMPLE RETURNED PASSED ALL FUNCTIONAL TESTS REQUIRED FOR THIS PRODUCT. PERFORMED TESTS AND PASSED ALL TESTS. SENSOR CABLE/ WIRES WAS EXPOSED TO FLEXING AND STRETCHING. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY. THE SENSOR DID NOT GENERATE ENERGY ITSELF, THE BURN COULD NOT BE CONFIRMED AS THE MONITOR IS THE SOURCE OF ENERGY TO THE SENSOR, AND ENERGY DELIVERED IS VERY LOW. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 BURN OR ULCERATION OF THE DOG'S TONGUE. IT WAS STATED THAT THE UNIT WAS ON THE DOG'S TONGUE AROUND 3 HOURS AND THE PART OF THE TONGUE COULD NOT BE SAVED. THE CUSTOMER HAD NO REPORTED PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864522 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA V-SAT 173520114H

    Patients

    Seq Age Sex Outcome Treatment
    1