BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7

    MDR report key: 4092965 · Received September 4, 2014

    Report

    Report Number
    2031172-2014-00174
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K061204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND ADD'L INFO REQUESTS WERE MADE. HOWEVER, THE DEVICE WAS NOT MADE AVAILABLE TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF AND WHEN INFO BECOMES AVAILABLE OR ONCE THE UNIT IS RETURNED AND AN EVAL IS PERFORMED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE ARE INTERMITTENT FAILURES OF THE DISPLAY (SOMETIMES IT LOSES THE IMAGE). NO PT INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541541 RADICAL-7 DQA MASIMO CORPORATION 20879

    Patients

    Seq Age Sex Outcome Treatment
    1