BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNCS RESUSABLE PULSE OXIMETRY SENSOR

    MDR report key: 17516388 · Received August 11, 2023

    Report

    Report Number
    MW5123337
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    March 25, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MASIMO CORPORATION (949) 297-7055
    Product Code
    DQA
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF AN EVENT THAT OCCURRED AT (B)(6) MEDICAL CENTER IN (B)(6) ON (B)(6) 2014 IN WHICH IT WAS ALLEGED A MASIMO LNCS REUSABLE PULSE OXIMETRY SENSOR PROVIDED INACCURATE OXYGEN SATURATION VALUES. AS A RESULT OF THIS ISSUE, THE PATIENT WAS INTUBATED AND PLACED ON A VENTILATOR. AT THE TIME OF THE EVENT, THE MASIMO SENSOR WAS CONNECTED TO A GE HEALTHCARE CARESCAPE B850 PATIENT MONITOR. ACCORDING TO THE CUSTOMER, THE SPO2 WAS READING 98-100%, HOWEVER THE ARTERIAL BLOOD GAS SHOWED 80%. THE HOSPITAL BIOMEDICAL TECHNICIAN AND MASIMO REPRESENTATIVE WERE ABLE TO REPRODUCE THE ISSUE WHEN THE SENSOR WAS INCORRECTLY APPLIED UPSIDE DOWN. THE GE HEALTHCARE CARESCAPE B850 MONITOR WAS TESTED AND FOUND TO BE WORKING IN ACCORDANCE WITH MANUFACTURER'S SPECIFICATIONS. THE MASIMO LNCS REUSABLE PULSE OXIMETRY SENSOR IS MANUFACTURED BY THE MASIMO CORPORATION WHICH IS HEADQUARTERED IN IRVINE, CA. THE MASIMO CORPORATION WAS INFORMED OF THIS EVENT ON (B)(6) 2014. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233737 LNCS RESUSABLE PULSE OXIMETRY SENSOR OXIMETER DQA MASIMO CORPORATION (949) 297-7055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown