BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNCS NEO

    MDR report key: 5100677 · Received September 24, 2015

    Report

    Report Number
    2031172-2015-01105
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 27, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K101896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT MICROFOAM TAPE WAS UTILIZED TO SECURE THE SENSOR. PER THE SENSOR'S DIRECTIONS FOR USE, "DO NOT USE TAPE TO SECURE THE SENSOR TO THE SITE; THIS CAN RESTRICT BLOOD FLOW AND CAUSE INACCURATE READINGS. USE OF ADDITIONAL TAPE CAN CAUSE SKIN DAMAGE, AND/OR PRESSURE NECROSIS OR DAMAGE THE SENSOR." IT WAS INDICATED BY THE CUSTOMER THAT THE SENSOR USED DURING THE REPORTED EVENT HAS BEEN DISCARDED; AND THEREFORE, COULD NOT BE RETURNED TO MASIMO FOR EVALUATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS A BURN FROM THE SENSOR. IT WAS NOTED THAT THE PATIENT'S BURN WAS NOT SEVERE; IT WAS A MINOR BURN. THE BURNED AREA WAS NOT TREATED. DURING USE, THE SENSOR WAS CHECKED/ROTATED EVERY EIGHT (8) HOURS. IT WAS ALSO REPORTED THAT MICROFOAM TAPE WAS UTILIZED TO SECURE THE SENSOR. NO OTHER DEVICES WERE USED CONCURRENTLY WITH THE SUBJECT DEVICE. NO OTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631901 LNCS NEO OXIMETER DQA MASIMO CORPORATION 2329

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Other