BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED DCI-DC3 SENSOR

    MDR report key: 5079621 · Received September 15, 2015

    Report

    Report Number
    2031172-2015-01100
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 22, 2015
    Report Date
    August 23, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K042536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER IS K042536.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEASURED VALUES ARE SOMETIMES LOW. THE VALUES WERE ALREADY MEASURED LOW AT ONE FACILITY, BUT WHEN MEASURED AT OTHER FACILITIES, THE VALUE IS LOWER. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609152 RED DCI-DC3 SENSOR OXIMETER DQA MASIMO CORPORATION 2053

    Patients

    Seq Age Sex Outcome Treatment
    1