BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE SENSOR

    MDR report key: 6806473 · Received August 19, 2017

    Report

    Report Number
    2031172-2017-00799
    Event Type
    Malfunction
    Date Received
    August 19, 2017
    Date of Event
    June 20, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MWI
    UDI-DI
    10843997005804
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE UNIT FAILED CONTINUITY TESTING DUE TO AN OPEN CONNECTION ON R1, R2, L2, CB, AND CT ELECTRODES. VISUAL INSPECTION CONFIRMED THERE IS NO PHYSICAL DAMAGE. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE SENSOR WAS RETURNED USED AND COULD NOT BE TESTED ON THE FOREHEAD., (BRAND NAME) WAS UPDATED FROM "SEDLINE" TO "SEDLINE SENSOR", (COMMON DEVICE NAME) WAS UPDATED FROM "ELECTROENCEPHALOGRAPH" TO "MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)", (PROCODE) WAS UPDATED FROM "GQW" TO "MWI", (EXPIRATION DATE) WAS UPDATED FROM A BLANK FIELD TO "10/01/2019", (REPORT SOURCE) WAS UPDATED FROM " FOREIGN; HEALTH PROFESSIONAL; USER FACILITY", TO "FOREIGN; COMPANY REPRESENTATIVE; USER FACILITY".

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFORMATION WERE MADE. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED OR THE PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PATIENT IS ANESTHETIZED ENOUGH BUT PSI SHOWED HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586491 SEDLINE SENSOR MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 40 PARKER 2479 17B29 10843997005804

    Patients

    Seq Age Sex Outcome Treatment
    1