BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-LNCS NEO-L

    MDR report key: 5488192 · Received March 9, 2016

    Report

    Report Number
    2031172-2016-00310
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    February 10, 2016
    Report Date
    February 16, 2016
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K060143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION RECEIVED, THIS REPORTED EVENT WAS CONFIRMED TO BE A DUPLICATE RECORD. SEE MFR# 2031172-2016-00311.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A GIVEN MOMENT, THE SPO2 READING FAILED AFTER 8 HOURS OF MEASUREMENT. IT WAS NOTED THERE WAS NO PATIENT MOVEMENT. THE ISSUE PERSISTED EVEN AFTER DISCONNECTING AND RECONNECTING THE SENSOR, BUT NO VALUE WAS DISPLAYED. THE CABLE WAS DISCONNECTED AND RECONNECTED WITH THE SAME RESULT. IT WAS VERIFIED THAT THE SENSOR EMITTER AND DETECTOR WERE ALIGNED. THE RED LIGHT WAS EMITTING. A NEW SENSOR AND DIFFERENT PATIENT CABLE WAS USED AND A GOOD PLETH AND VALUE WERE DISPLAYED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145668 M-LNCS NEO-L OXIMETER DQA MASIMO CORPORATION 25114 14NGY

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention