BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS NEO ADH SENSOR

    MDR report key: 3947658 · Received July 11, 2014

    Report

    Report Number
    2031172-2014-00108
    Event Type
    Other
    Date Received
    July 11, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K051212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSOR INVOLVED IN THIS EVENT WAS NOT RETURNED, HOWEVER RETAINED SAMPLES WERE AVAILABLE FOR EVALUATION. THE SENSOR WAS EVALUATED AND PASSED ALL TESTING INCLUDING A VISUAL EVALUATION, CONTINUITY TESTING AND SKIN TEMPERATURE VERIFICATION. THE SENSOR TESTED WAS CONFIRMED TO FUNCTION AS DESIGNED. A PRODUCT LABELING REVIEW WAS CONDUCTED WHICH INCLUDED REVIEWING THE DIRECTIONS FOR USE (DFU). THE USER FACILITY WAS CONTACTED AND APPROPRIATE INSTRUCTION AND CLARIFICATION WAS PROVIDED TO AUGMENT TRAINING THEY HAVE ALREADY RECEIVED. INFO MASIMO RECEIVE INDICATED THAT THE PT IS DOING FINE OUTSIDE OF THEIR UNDERLYING CONDITION. THE PT HAS BEEN DISCHARGED FROM THE PICU.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING: "OUR PICU IS OBSERVING A RECENT INCREASE IN SMALL BLACKISH/ "BURN" MARKS DIRECTLY UNDER THE LIGHT SOURCE OF THE LNCS-NEO PULSE OXIMETER PROBE. HAVE YOU HEARD ANY SIMILAR COMPLAINTS FROM OTHER HOSPITALS? WE ARE NOT SURE IF IT IS PRODUCT OR USER RELATED. THE STAFF IS SUPPOSED TO RE-POSITION THE SENSORS EVERY 6 HRS, AND WE ARE NOT SURE THIS IS CONSISTENTLY BEING DONE. ANY INSIGHT WOULD BE GREAT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407860 LNCS NEO ADH SENSOR DQA MASIMO CORPORATION 2329 K14EBT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other