BEUDAMED
    FDA Adverse Event Other Summary report: N

    M-LNCS NEO

    MDR report key: 3940592 · Received April 18, 2014

    Report

    Report Number
    2031172-2014-00040
    Event Type
    Other
    Date Received
    April 18, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K111888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISPOSED OF BY THE CUSTOMER AND COULD NOT BE RETURNED FOR EVALUATION TO THE MANUFACTURER. INFORMATION WAS MADE AVAILABLE TO MASIMO BY THE USER FACILITY THAT THE PATIENT WAS ADMINISTERED BISEPTINE TO DISINFECT THE SKIN AND BIAFINE CREAM, A SKIN MOISTURIZER. THE PATIENT WAS OBSERVED BY THE CUSTOMER ON (B)(6) 2014 AND THE CUSTOMER REPORTED THAT THE PATIENT WAS "OKAY." ADDITIONAL EVENT DETAILS WERE OBTAINED AND IT HAS BEEN NOTED THAT THE CUSTOMER USED COHEBAN WRAP TO ADHERE THE SENSOR TO THE PATIENT. A PRODUCT LABELING REVIEW WAS CONDUCTED, PER THE DIRECTIONS FOR USE, "DO NOT USE TAPE TO SECURE THE SENSOR TO THE SITE; THIS CAN RESTRICTS BLOOD FLOW AND 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 WAS PROVIDED APPROPRIATE INSTRUCTION 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 INITIALLY REPORTED THAT THE CUSTOMER WAS 'HAVING A BIG SAFETY ISSUE WITH SPO2 SENSORS." IT WAS LATER REPORTED THAT THE ISSUE WAS RELATED TO PATIENT EDEMA IN THE NEONATOLOGY DEPARTMENT. A MASIMO CLINICAL SPECIALIST WENT TO THE CUSTOMER'S SITE ON (B)(4) 2014. THE STAFF'S AVAILABILITY WAS LIMITED, BUT THE CLINICAL SPECIALIST WAS ABLE TO PROVIDE ADDITIONAL EDUCATIONS ON POSITIONING THE SENSOR. ADDITIONAL MEETINGS WITH THE STAFF WERE REQUESTED ON (B)(4) 2014, BOTH OF WHICH WERE CANCELLED BY THE CUSTOMER AFTER THE CLINICAL SPECIALIST ARRIVED ON SITE. THE CHIEF OF NURSING TOLD THE CLINICAL SPECIALIST THERE WERE NO FURTHER INCIDENTS SINCE THE INITIAL VISIT ON (B)(4) 2014. THE CUSTOMER COMMUNICATED THAT THE EDEMA THEY OBSERVED WAS THE RESULT OF THEIR USE OF COBAN TAPE ON THE SENSOR. ON (B)(4) 2014, THE CLINICAL SPECIALIST WAS ABLE TO SECURE A MEETING WITH THE HOSPITAL STAFF. AT THIS TIME, ADDITIONAL EDUCATION PERTAINING TO DIRECTIONS FOR USE WAS ADMINISTERED TO THE NEONATOLOGY NURSING STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238732 M-LNCS NEO DQA MASIMO CORPORATION M-LNCS NEO

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other