BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8, HORIZONTAL

    MDR report key: 4213236 · Received October 2, 2014

    Report

    Report Number
    2031172-2014-00223
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT INTERMITTENTLY SHUTS DOWN WHILE ENGAGED IN PT MONITORING. THIS EVENT OCCURS ON BOTH AC AND DC POWER. THE CUSTOMER STATES THE UNIT IT CABLE OF BEING POWERED ON AGAIN. HOWEVER, INTERMITTENT SHUTDOWN CONTINUES. NO PT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615837 RAD-8, HORIZONTAL OXIMETER DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1