BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNCS TF-I

    MDR report key: 5105081 · Received September 25, 2015

    Report

    Report Number
    2031172-2015-01125
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K051212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE SENSOR USED FOR THIS EVENT WAS DISCARDED AND THE SENSOR LOT INFORMATION WAS NOT AVAILABLE. IF NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IT WAS REPORTED THE SENSOR WAS MOVED APPROXIMATELY EVERY FOUR (4) HOURS. A PRODUCT LABELING REVIEW WAS CONDUCTED, WHICH INCLUDED REVIEWING THE DIRECTIONS FOR USE (DFU). PER THE SENSOR'S DIRECTION FOR USE, "THE LNCS TF-I MUST BE REMOVED AND REPOSITIONED TO A DIFFERENT MONITORING SITE AT LEAST EVERY TWO (2) HOURS." THE USER FACILITY WAS CONTACTED AND APPROPRIATE INSTRUCTIONS AND CLARIFICATION WAS PROVIDED TO AUGMENT TRAINING THEY HAVE ALREADY RECEIVED AND TO ENSURE THE PROPER USE OF THE DEVICE IS CLEARLY UNDERSTOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INJURED BY THE FOREHEAD SENSOR. THE PATIENT'S AGE WAS APPROXIMATED TO BE 65-80 YEARS OLD. IT WAS NOTED THERE WAS TWO DARK-BROWN ROUND CIRCLES ON THE PATIENT'S FOREHEAD ABOUT 1.5 INCHES IN DIAMETER. THE PATIENT APPEARED TO HAVE A HEMATOMA UNDER THE SKIN. THE SENSOR WAS MOVED APPROXIMATELY EVERY FOUR (4) HOURS. IT WAS ALSO NOTED THE FOREHEAD SENSOR WAS USED AS THE PATIENT HAD LOW PERFUSION ON THE FINGERS AND TOES AND WAS BEING TREATED WITH "LEVO AND EPI." THE PATIENT EXPIRED 1-2 DAYS LATER DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634576 LNCS TF-I OXIMETER DQA MASIMO CORPORATION 1896

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O