BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNOP NEO-L

    MDR report key: 4093002 · Received September 5, 2014

    Report

    Report Number
    2031172-2014-00172
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K040214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADD'L INFO WERE MADE. THE SENSOR HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED OR THE SENSOR IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "MASIMO PR NOT CORRELATING WITH THE EKG HR READING ON THE MONITOR (READING DOUBLE THE COUNT)". NO PT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545950 LNOP NEO-L DQA MASIMO CORPORATION 1798

    Patients

    Seq Age Sex Outcome Treatment
    1 GE TRAM