BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS-7

    MDR report key: 4902754 · Received July 2, 2015

    Report

    Report Number
    2031172-2015-00908
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 5, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K142394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFORMATION WERE MADE. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED OR THE PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER IS 9664. THE PRODUCT WAS RETURNED TO THE MANUFACTURER ON 06/30/2015. THE 510K NUMBER IS K142394.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE UNIT WAS ABLE TO POWER ON AND AN AUDIBLE BEEP WAS HEARD, HOWEVER, THE BATTERY MODULE LCD SCREENS DID NOT ILLUMINATE. THE LCD SCREENS WAS FULLY FUNCTIONAL AFTER A POWER RESTART WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS AN LCD ISSUE AND A DEFECTIVE BATTERY. IT IS UNKNOWN IF THERE ARE ALARMS OR ERROR MESSAGES NOTIFYING THE USER OF A MALFUNCTION. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433113 RADIUS-7 OXIMETER DQA MASIMO CORPORATION 24970

    Patients

    Seq Age Sex Outcome Treatment
    1