BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL DOCKING STATION

    MDR report key: 3983500 · Received June 26, 2014

    Report

    Report Number
    2031172-2014-00094
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K061204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE CUSTOMER INDICATED THAT THE DEVICE WILL BE RETURNED TO MASIMO FOR EVALUATION; AS OF (B)(6) 2014, THE DEVICE HAS NOT BEEN RECEIVED BY MASIMO. A VIDEO WAS MADE AVAILABLE TO MASIMO FOR REVIEW AND THE EVALUATION IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED. NO PATIENT INCIDENT WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FOLLOWING "THE VIDEO SHOWS THE DIFFERENCE BETWEEN MEASUREMENTS ON MY RADICAL AND THE HOSPITAL'S INTELLIVUE - BOTH USING THE SAME LNCS NEO SENSORS, BOTH ON THE SAME PATIENT, BOTH ON THE SAME FOOT. THE DELTA APPEAR TO BE 4 TO 6 PERCENT LOWER O SAT READINGS ON THE INTELLIVUE. THIS DELTA APPEARS TO ME TO BE CONSISTENT IN DIFFERENT ROOMS (ON VARIOUS INTELLIVUE SYSTEMS)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373873 RADICAL DOCKING STATION DQA MASIMO CORPORATION 1310

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR PHILIPS INTELLIVUE