BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS INF

    MDR report key: 3878029 · Received May 30, 2014

    Report

    Report Number
    2031172-2014-00050
    Event Type
    Other
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K094046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # UPDATED TO K14CEN. ADDED MASIMO RAD-8 PULSE OXIMETER AND MASIMO LNC-10 PATIENT CABLE. DEVICE MANUFACTURE DATE UPDATED TO 03/06/2014.

    Additional Manufacturer Narrative · 1

    THE SENSOR INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE SENSOR WAS EVALUATED AND PASSED ALL TESTING INCLUDING A VISUAL EVALUATION, CONTINUITY TESTING AND SKIN TEMPERATURE VERIFICATION. THE RETURNED SENSOR WAS CONFIRMED TO FUNCTION AS DESIGNED. BASED ON A REVIEW OF THE PICTURE PROVIDED BY THE END USER OF THE SENSOR PLACEMENT AS WELL AS VISUAL INSPECTION OF THE RETURNED SENSOR, IT APPEARS THAT COHEBAN WRAP MAY HAVE BEEN USED TO SECURE THE SENSOR TO THE CHILD'S FOOT. A PRODUCT LABELING REVIEW WAS CONDUCTED, WHICH INCLUDED REVIEWING THE DIRECTIONS FOR USE (DFU). PER THE DIRECTIONS FOR USE, THE FOLLOWING IS INDICATED "DO NOT USE TAPE TO SECURE THE SENSOR TO THE SITE; THIS CAN CAUSE INACCURATE READINGS. USE OF ADDITIONAL TAPE CAN CAUSE SKIN DAMAGE, AND/OR PRESSURE NECROSIS OR DAMAGE TO THE SENSOR." THE USER WAS CONTACTED BY MASIMO AND PROVIDED APPROPRIATE INSTRUCTIONS AND CLARIFICATION TO AUGMENT THE TRAINING THEY HAD ALREADY RECEIVED AND TO CONFIRM PROPER USE OF THE SENSOR WAS CLEARLY UNDERSTOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MASIMO SENSOR CAUSED A "RED BLISTER" ON AN INFANT'S FOOT. THE MOM STATES SHE NOTICED A SMALL RED MARK ON THE PATIENT'S FOOT ON APRIL 23RD WHICH GOT BIGGER ON THE 24TH AND THEN BECAME A FULL BLISTER BY THE 25TH. IN ADDITION, THE MOM STATES THAT THEY WERE CHANGING THE PROBE AND THROWING IT AWAY 2 TIMES A WEEK, USUALLY ON A MONDAY AND A THURSDAY. THE BURN CREAM CALMOSEPTINE WAS BEING APPLIED TO THE AFFECTED AREA AND IT IS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318863 LNCS INF DQA MASIMO CORPORATION LNCS INF K14CEN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other