BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNCS ADTX

    MDR report key: 5062632 · Received September 8, 2015

    Report

    Report Number
    2031172-2015-01069
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 7, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K060143
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR THE RETURN OF THE SENSOR AS WELL AS ADDITIONAL INFORMATION REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE SENSOR INVOLVED IN THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADTX SENSOR WAS DIFFICULT TO REMOVE AND HAS CAUSED A SKIN TEAR ON ONE OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593582 LNCS ADTX OXIMETER DQA MASIMO CORPORATION 1859

    Patients

    Seq Age Sex Outcome Treatment
    1 Other