BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 8738077 · Received June 26, 2019

    Report

    Report Number
    9610849-2019-00016
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Report Date
    October 30, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS DONE. TEST SHOWED THAT THE BLACK AND RED WIRES OF THE EMITTER FAILED. THE CABLE AND INTERNAL BLACK AND RED WIRES ARE WORN, THIS COULD BE CLASSIFIED AS AN OVERUSED. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE SENSOR CAUSED A LOW TEMPERATURE BURN ON AN ANIMAL. IT WAS REPORTED THAT THEY USED SENSOR CLIPS TO CHANGE THE ATTACHING PORTION WITH INTERVALS OF FIVE MINUTES AND THE TONGUE DISCOLORED TO WHITE AT TWO SITES, CENTER AND END. AFTER THAT, THE END SITE HAD ABSENCE WHICH SEEMS THE OCCURRENCE OF LOW TEMPERATURE HARM HAD SWELLED.

    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 SENSOR CAUSED A LOW TEMPERATURE TO BURN ON AN ANIMAL. THE CUSTOMER REPORTED THAT THE TONGUE HAD DISCOLORED TO WHITE AT 2 SITES, CENTER AND END. AFTER THAT, THE END SITE HAD ABSENCE WHICH SEEMS THE OCCURRENCE OF LOW TEMPERATURE HARM HAD SWELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531500 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA V-SAT 163300164H 10884522042468

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other