BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-5V

    MDR report key: 3982786 · Received June 13, 2014

    Report

    Report Number
    2031172-2014-00076
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K033998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED ON (B)(4) 2014 TO THE MANUFACTURER FOR EVAL. ONCE THE INVESTIGATION ON THE UNIT IS PERFORMED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RAD5V READS SOME VALUES WITHOUT HAVING ANY FINGER PLUGGED INTO IT. IT HAD VALUES OF 86/60 WITHOUT ANY FINGERS ON SENSOR. NO PT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351322 RAD-5V DQA MASIMO CORPORATION RAD-5V

    Patients

    Seq Age Sex Outcome Treatment
    1