BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINBOW DCI-DC3 SP02/SPCO/SPMET

    MDR report key: 4531910 · Received January 14, 2015

    Report

    Report Number
    2031172-2015-00115
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Date of Event
    December 14, 2014
    Report Date
    December 15, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K080238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR # WAS 2031172-2014-00115. HOWEVER, THE CORRECT MDR # SHOULD BE 2031172-2015-00115.

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVAL OR NEW INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPCO MEASUREMENT WAS INDICATED OVER 10% WITH THE RAD-57. SPO2 MEASUREMENT WAS FUNCTIONED PROPERLY. IT WAS REPORTED THAT THE ANTI-LIGHTING WAS SET, PI WAS QUITE NORMAL, AND NO LOWSIQ CAME UP. EMS MANAGER CONFIRMED THE TREND. THE REPORTED EVENT WAS AN OUT OF BOX OBSERVATION, DURING THE CHECK. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31972 RAINBOW DCI-DC3 SP02/SPCO/SPMET OXIMETER DQA MASIMO CORPORATION 24089 A14H806

    Patients

    Seq Age Sex Outcome Treatment
    1