BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS NEO ADHESIVE SENSORS

    MDR report key: 3736347 · Received April 2, 2014

    Report

    Report Number
    2031172-2014-00035
    Event Type
    Other
    Date Received
    April 2, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND ADD'L INFO REQUESTS WERE MADE. THE UNIT WAS NOT RETURNED TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. A LABEL REVIEW WAS CONDUCTED, IT WAS NOTED THAT THE DIRECTIONS FOR USE (DFU) FOR THIS SENSOR PROVIDES A WARNING TO "CAREFULLY ROUTE CABLE AND PATIENT CABLE TO REDUCE THE POSSIBILITY OF PATIENT ENTANGLEMENT OR STRANGULATION."

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER: "I HAVE BEEN USING THE RAD 8 MONITOR AT HOME FOR 6 MONTHS. I AM WONDERING IF THESE UNITS ARE ACTUALLY TESTED ON ACTIVE BABIES IN A HOME SETTING. EVERY PARENT I HAVE TALKED TO REGARDING THEIR MONITORS ARE NOT IMPRESSED WITH THIS SYSTEM. FLAWS WITH THIS SYSTEM:1. WHERE THE PATIENT CABLE AND SENSOR ATTACH IS FAR TOO HEAVY. IT PULLS THE SENSOR OFF THE FOOT AND GIVES A BAD SIGNAL. 2. THE AREA WHERE THE SENSOR AND THE CORD ATTACH BY WHITE TAPE IS A VERY POOR DESIGN. IT BENDS AND TWISTS AND LIMITS THE LIFE OF THE SENSOR AND THE WIRES BECOME EXPOSED ON OCCASION FROM BABY'S REPETITIVE MOVEMENTS (IE CRAWLING, JUMPING, STANDING, WALKING, RUNNING). 3. CAN'T GET A GOOD READING FROM THE MONITOR DURING PLAY. AS MY CHILD HAS HEART ISSUES, THIS IS WHEN I NEED THE MONITOR TO WORK AND IT DOES NOT. ALSO, THE PATIENT CABLE IS WRAPPING AROUND MY SON'S BODY AND NECK DURING PLAY AND SLEEP. THIS IS A SAFETY CONCERN. THE CORD ON ONE OCCASION WRAPPED ITSELF SO TIGHT AROUND MY SON'S ARM IT BRUISED HIM FOR SEVERAL WEEKS. WHAT IF THAT HAD BEEN AROUND HIS NECK? I'M VERY DISAPPOINTED WITH THE RAD 8." IT WAS LATER REPORTED BY THE USER THAT "THE BATTERY LIFE OF THE INSTRUMENT DECREASES WITHIN A WEEK OR TWO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199971 LNCS NEO ADHESIVE SENSORS DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other