BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8 HORIZONTAL

    MDR report key: 4093000 · Received September 5, 2014

    Report

    Report Number
    2031172-2014-00178
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT KEEOS TURNING ITSELF OFF BY ITSELF. THERE WERE NO ALARMS OR ERROR MESSAGES. NO PT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546410 RAD-8 HORIZONTAL DQA MASIMO CORPORATION 9190

    Patients

    Seq Age Sex Outcome Treatment
    1