BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 6878232 · Received September 20, 2017

    Report

    Report Number
    2936999-2017-05487
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Report Date
    October 31, 2017
    Manufacturer
    NELLCOR PURITAN BENNETT MEXICO SA
    Product Code
    DQA
    PMA / PMN Number
    K123581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE OF THE V-SAT VETERINARY SENSOR LOT # 162600130H WAS RECEIVED FOR EVALUATION AND THE CUSTOMER REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE SENSOR SHOWED USAGE. FUNCTIONAL EVALUATION AND TESTING WAS PERFORMED AND IT WAS FOUND THAT THE PASSED SATURATION AND PULSE READINGS. CONTINUITY TESTS WERE PERFORMED AND THE OXIBAND FUNCTIONAL TEST SHOWED THAT THE SENSORS PASSED IN THE EMITTER. THE SENSOR CABLE AND WIRES WAS/WERE EXPOSED TO FLEXING AND STRETCHING. THE SENSOR PASSED EPROM TESTING. WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT HOWEVER, MANUFACTURING CONTROLS AND TESTING ARE IN PLACE TO DETECT DEFECTIVE PRODUCT AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE UNIT WAS GIVING LOW READINGS. THERE HAD BEEN ANIMAL INVOLVEMENT BUT NO ANIMAL HARM. THE CUSTOMER REPORTED THE PRODUCT HAD BEEN READING 80'S AND LOW 90'S. THE CUSTOMER WAS USING A CARDELL MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659275 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA V-SAT

    Patients

    Seq Age Sex Outcome Treatment
    1