BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL - 7 BLUE SCREEN

    MDR report key: 4932642 · Received July 17, 2015

    Report

    Report Number
    2031172-2015-00949
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 19, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER SIX (6) YEARS WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE WON'T ALLOW LIMITS TO BE CHANGED. THE SCREEN WOULD FLICK BACK BEFORE LIMITS CAN BE ALTERED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SCREEN WOULD REFRESH WHEN THE MENU WAS OPEN AND THE USER WOULD THEN BE UNABLE TO CHANGE THE ALARM LIMITS. ALSO, A PIN WAS FOUND TO BE STUCK ON THE HANDHELD WHICH WASN'T MAKING CONTACT WITH THE DOCKING STATING CONNECTOR. THE PIN WAS ADJUSTED SO THAT IT MOVED FREELY. THIS PARTIALLY CORRECTED THE FAULT, BUT IT WAS STILL INTERMITTENT. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465259 RADICAL - 7 BLUE SCREEN OXIMETER DQA MASIMO CORPORATION 21744

    Patients

    Seq Age Sex Outcome Treatment
    1