BEUDAMED
    FDA Adverse Event Death Summary report: N

    RED LNC-10

    MDR report key: 3872118 · Received May 30, 2014

    Report

    Report Number
    2031172-2014-00051
    Event Type
    Death
    Date Received
    May 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K042536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CABLE INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. NO EXTERNAL DAMAGE WAS OBSERVED. THE RETURNED DEVICE PASSED ALL FUNCTIONAL TESTING INCLUDING A VISUAL EVAL, CONTINUITY AND INTERMITTENCY. THE CABLE WAS FOUND TO BE FUNCTIONING AS DESIGNED. THE PRODUCT WAS RETURNED TO THE CUSTOMER AFTER EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THIS UNIT DID NOT ALARM DURING A PT DE-SATURATION. THE CUSTOMER STATES THAT AFTER RECEIVING THE UNIT BACK FROM THE END USER, THEY TESTED THE UNIT WITH THEIR OWN CABLE AND SENSOR AND FOUND THAT THE UNIT WAS ALARMING CORRECTLY WHEN IT SURPASSED A SPO2 LIMIT THAT THEY PURPOSELY SET TO A LEVEL THAT ALLOWED THEM TO TEST IT. THE SENSOR USED DURING THE REPORTED EVENT IS NO LONGER AVAILABLE AS IT HAS BEEN DISCARDED BY THE END USER. THE LOT NUMBER OF THE SENSOR IS UNK AS WELL. ADD'L INFO REC'D FROM THE CUSTOMER ON (B)(6) 2014, THE CUSTOMER INDICATED THAT THE PT PASSED AWAY BECAUSE OF THIS INCIDENT; THE MOTOR THOUGH THE PT WAS ASLEEP UNTIL THE VENTILATOR STARTED TO ALARM; THE FATHER KNEW SOMETHING WAS WRONG; THE SENSOR WAS DISCARDED; THE SENSOR LOT NUMBER IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319295 RED LNC-10 DQA MASIMO CORPORATION 13DJE

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Death VENTILATOR