BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE SENSOR

    MDR report key: 7233096 · Received January 31, 2018

    Report

    Report Number
    2031172-2018-00037
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    December 19, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    MWI
    UDI-DI
    10843997005804
    PMA / PMN Number
    K151644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING THIS EVALUATION, THE SENSOR PASSED VISUAL INSPECTION; HOWEVER, FAILED CONTINUITY TESTING DUE TO OPEN R1, R2, L1, L2, CB, CT ACROSS THE ELECTRODES. ADDITIONALLY, THE SENSOR WAS RETURNED USED AND COULD NOT BE TESTED ON FOREHEAD. CORRECTED DATA: (PROCODE): UPDATED FROM "DQA" TO "MWI".

    Description of Event or Problem · 1

    IT WAS REPORTED "PSI SHOWS TOO HIGH VALUE WHILE PATIENT WAS ANESTHETIZED." NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75448 SEDLINE SENSOR OXIMETER MWI MASIMO - 40 PARKER 4248 10843997005804

    Patients

    Seq Age Sex Outcome Treatment
    1