BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNOP DCI-P

    MDR report key: 4213256 · Received October 3, 2014

    Report

    Report Number
    2031172-2014-00222
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K033998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    "THE RETURNED DEVICE WAS EVALUATED. DURING AN INTERNAL INSPECTION OF THE DEVICE, THE SENSOR WAS FOUND TO HAVE A SHORT ON THE DETECTOR CIRCUIT. THE RETURNED RAD-5 WAS UNABLE TO OBTAIN ANY READING AND A "SEN OFF" MESSAGE WAS DISPLAYED". A LOT REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER EIGHT YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    PROBLEM: INCORRECT READING OF SPO2, BIOMED TESTED IT AND GAVE A WRONG READING 87/88%. WITH THE SAME SENSOR ON A RADICAL WHICH WORKS PROPERLY BIOMED GIVE A CORRECT READING OF 98/99%. NO PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620970 LNOP DCI-P OXIMETER DQA MASIMO CORPORATION 1276 A06B051

    Patients

    Seq Age Sex Outcome Treatment
    1