BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS TC-I OXIMETRY SENSOR

    MDR report key: 3901554 · Received June 11, 2014

    Report

    Report Number
    2031172-2014-00073
    Event Type
    Other
    Date Received
    June 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 30, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K041815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION REQUEST HAVE BEEN MADE IN ORDER TO IDENTIFY THE SENSOR INVOLVED IN THE REPORTED EVENT. TESTING OF RETAINED SAMPLES IS CURRENTLY UNDERWAY. THIS ISSUE WAS NOT REPORTED IN A TIMELY MANNER BY FIELD PERSONNEL. A DISCUSSION WITH THE REPORTER WAS HELD INFORMING THEM OF THE IMPORTANCE OF REPORTING. FORMAL TRAINING IN THE REQUIREMENT OF TIMELY REPORTING OF CUSTOMER COMPLAINTS HAS BEEN PERFORMED WITH THE RESPONSIBLE REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT "MARQUE AVEC ROUGEUR" (RED SIGNS) WERE SEEN ON THE PATIENT'S SKIN. THE CUSTOMER WAS BEING MONITORED ON A PHILIPS MP70 MONITOR USING A MASIMO LNCS TC-I SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344959 LNCS TC-I OXIMETRY SENSOR DQA MASIMO CORPORATION LNCS TC-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other