BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS OXIMETRY SENSORS

    MDR report key: 3601610 · Received January 10, 2014

    Report

    Report Number
    2031172-2014-00005
    Event Type
    Other
    Date Received
    January 10, 2014
    Date of Event
    December 6, 2013
    Report Date
    December 11, 2013
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K041815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSOR INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION BY THE CUSTOMER DESPITE MASIMO'S MULTIPLE ATTEMPTS TO HAVE THE SENSOR RETURNED. INFORMATION WAS ALSO MADE AVAILABLE TO MASIMO INDICATING THAT THE SKIN ABNORMALITY HAS HEALED/RESOLVED ON ITS OWN. SINCE THE SENSOR INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED, MASIMO EVALUATED A SENSOR FROM THE SAME MANUFACTURING LOT. THE RETAINED/TESTED SENSOR PASSED ALL TESTING INCLUDING A VISUAL EVALUATION, CONTINUITY TESTING AND SKIN TEMPERATURE VERIFICATION. THE RETAINED SENSOR WAS CONFIRMED TO FUNCTION AS DESIGNED. THE CUSTOMER'S HOME HEALTH NURSE INDICATED THAT A VELCRO WRAP WAS BEING USED TO LOOSELY 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 THE SENSOR." THE USER WAS DIRECTLY CONTACTED BY MASIMO AND WE 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 THE SENSOR IS BURNING OR BLISTERING A PREMATURE CHILD'S FOOT. MOVED TO THE OTHER FOOT DID THE SAME THING. THEN MOVED TO THE WRIST AND STILL GOT RED BUT DIDN'T BURN OR BLISTER. MOTHER TOOK THE CHILD TO THE HOSPITAL, NOT AS A RESULT OF THE BURNS, BUT BECAUSE THE CHILD WAS TURNING BLUE. MOTHER ALSO INDICATED THAT THEY WOULD ADD A VELCRO TYPE WRAP TO THE CHILD'S FOOT BECAUSE THE SENSOR WOULD NOT STAY ON ALL THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17894 LNCS OXIMETRY SENSORS DQA MASIMO CORPORATION LNCS Y-I 13HBR

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other