BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNCS ADTX SENSOR

    MDR report key: 4860098 · Received June 18, 2015

    Report

    Report Number
    2031172-2015-00865
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K101896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GAVE THE PT A SENSATION OF HEAT/BURNING [ON THE SKIN]. THE CUSTOMER WAS UNABLE TO DETERMINE WHICH SPECIFIC SENSOR WAS INVOLVED. THE CUSTOMER LSO REPORTED THAT THERE WERE NO CONSEQUENCES OR IMPACT TO PT BUT THE EVENT DID DELAY CARE FOR THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397063 LNCS ADTX SENSOR DQA MASIMO CORPORATION 1859 K14KYA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other