BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS NEO ADHESIVE

    MDR report key: 3818199 · Received May 9, 2014

    Report

    Report Number
    2031172-2014-00045
    Event Type
    Other
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND ADDITIONAL INFO REQUESTS WERE MADE. TO DATE, THE UNIT HAS NOT BEEN RETURNED TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. ADDITIONAL EVENT DETAILS WERE OBTAINED AND IT HAS BEEN NOTED THAT THE CUSTOMER WAS USING THE LNCS NEO SENSOR ON A (B)(6) KG BABY. A PRODUCT LABELING REVIEW WAS CONDUCTED. PER THE DIRECTIONS FOR USE, THE LNCS NEO SENSOR IS INDICATED FOR USE ON PTS WEIGHING LESS THAN 3 KG OR MORE THAN 40 KG. THE END USER WAS CONTACTED AND APPROPRIATE INSTRUCTION AND CLARIFICATION WAS PROVIDED TO AUGMENT TRAINING HE HAD ALREADY RECEIVED AND TO ENSURE SENSOR WEIGHT REQUIREMENTS ARE CLEARLY UNDERSTOOD. IF THE SENSOR OR NEW INFO IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE CUSTOMER: "THE SENSOR THEY ARE CURRENTLY USING IS LEAVING A BURN MARK ON HIS DAUGHTER'S FOOT AND WOULD LIKE A RECOMMENDATION FROM MASIMO ON A DIFFERENT SENSOR TO USE. IT IS DIFFICULT TO GET A READING WITH THE SENSOR." THE CUSTOMER APPLIES THE SENSOR TO THE FOOT, BIG TOE, OR THE HANDS. THE SENSOR WAS DESCRIBED AS LEAVING CIRCLE MARKS ON THE BABY'S FOOT AND, AFTER THE SENSOR WAS ON FOR EIGHT HOURS, THE DOT REMAINED FOR TWO WEEKS. THE CUSTOMER REQUESTED MORE INFO REGARDING THE LNCS NEONATAL SOFT TOUGH SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282141 LNCS NEO ADHESIVE DQA MASIMO CORPORATION LNCS NEO

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other