BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS NEO NEONATAL SPO2 ADHESIVE SENSORS

    MDR report key: 3651370 · Received February 14, 2014

    Report

    Report Number
    2031172-2014-00010
    Event Type
    Other
    Date Received
    February 14, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 17, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K060143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSOR INVOLVED IN THIS EVENT WAS DISCARDED BY THE CUSTOMER. HOWEVER, ANOTHER SENSOR SAMPLE WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. THE RETURNED SENSOR PASSED ALL TESTING INCLUDING A VISUAL EVALUATION, CONTINUING TESTING, AND SKIN TEMPERATURE VERIFICATION. THE RETURNED SENSOR WAS CONFIRMED TO BE FUNCTIONING AS DESIGNED. THE CUSTOMER INDICATED THAT THE SENSOR WAS BEING ASSESSED EVERY 8 HOURS. A PRODUCT LABELING REVIEW WAS CONDUCTED WHICH INCLUDED REVIEWING THE DIRECTIONS FOR USE (DFU). THE USER FACILITY WAS CONTACTED AND APPROPRIATE INSTRUCTIONS AND CLARIFICATION WAS PROVIDED AND TO ENSURE THE PROPER USE OF THE DEVICE IS CLEARLY UNDERSTOOD. INFORMATION MASIMO RECEIVED INDICATED THE PATIENT'S PRESSURE ULCER HEALED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSOR IS CAUSING PRESSURE ULCER ON INFANT WHILE THE SENSOR WAS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97065 LNCS NEO NEONATAL SPO2 ADHESIVE SENSORS DQA MASIMO CORPORATION NEO K13N45

    Patients

    Seq Age Sex Outcome Treatment
    1 Other