BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 COLOR SCREEN HANDHELD

    MDR report key: 4950251 · Received July 22, 2015

    Report

    Report Number
    2031172-2015-00944
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 21, 2015
    Report Date
    June 21, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE UNIT WAS ABLE TO POWER ON, HOWEVER, LINES AND DISCOLORATION WERE OBSERVED ON THE DISPLAY. THE MEASUREMENTS ARE VISIBLE, BUT THEY ARE DIFFICULT TO READ. THE LCD WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER THREE (3) YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY SHOWS STRIPES AND THE COLOR IS FADING. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE ARE LINES ON THE DISPLAY AND THE COLOR GOES AWAY SLOWLY. THE LINES ARE OBSTRUCTING THE VALUES, HOWEVER, THE VALUES DO APPEAR ARE FUNCTIONING AS DESIGNED DURING ALARM CONDITIONS. THE DEVICE IS STILL ABLE TO ENGAGE IN MONITORING ACTIVITIES UNDER THIS CONDITION. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474211 RADICAL-7 COLOR SCREEN HANDHELD OXIMETER DQA MASIMO CORPORATION 22539

    Patients

    Seq Age Sex Outcome Treatment
    1