BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7

    MDR report key: 5072498 · Received September 11, 2015

    Report

    Report Number
    2031172-2015-01089
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING THIS TESTING THE UNIT WAS ABLE TO POWER ON, HOWEVER, THE LCD DISPLAY LOOKED CRACKED AND HAD LINES ACROSS THE SCREEN. THE LCD WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A PROBLEM WITH THE SCREEN. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601606 RADICAL-7 OXIMETER DQA MASIMO CORPORATION 25052

    Patients

    Seq Age Sex Outcome Treatment
    1