BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8, HORIZONTAL

    MDR report key: 3872133 · Received May 30, 2014

    Report

    Report Number
    2031172-2014-00052
    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 DEVICE RETURNED THAT WAS INVOLVED IN THE REPORTED EVENT WAS EVALUATED. A VISUAL INSPECTION OF THE EXTERNAL SURFACES OF THE DEVICE CONCLUDED NO EXTERNAL DAMAGE TO WAS OBSERVED. A SPO2 SIMULATOR WAS USED TO VERIFY THE FUNCTIONALITY OF SPO2 AND PULSE RATE, IT WAS FOUND TO BE FUNCTIONING AS DESIGNED. TESTING WAS ALSO PERFORMED USING A KNOWN GOOD SENSOR. TESTING SHOWED THE UNIT TO PROVIDE BOTH AUDIBLE AND VISUAL ALARM WHEN THE ALARM THRESHOLDS FOR LOW SPO2 WERE REACHED.

    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
    319296 RAD-8, HORIZONTAL DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Death VENTILATOR