BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNCS ADTX ADHESIVE SENSOR

    MDR report key: 4990563 · Received August 5, 2015

    Report

    Report Number
    2031172-2015-00996
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K060143
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE EXPERIENCING PROBLEMS WITH NOT PICKING UP OR ARE PICKING UP INACCURATELY ON THE MOST POORLY PERFUSED PATIENTS. ADDITIONAL INFORMATION RECEIVED STATED THE PATIENT REQUIRED REINTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515821 LNCS ADTX ADHESIVE SENSOR OXIMETER DQA MASIMO CORPORATION 1859

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LNC MP10 CABLE