BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-LNCS ADTX

    MDR report key: 5060929 · Received September 8, 2015

    Report

    Report Number
    2031172-2015-01061
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K060143
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND ADDITIONAL INFORMATION REQUESTS WERE MADE. THE UNIT HAS NOT BEEN RETURNED TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE INACCURATE SPO2 READINGS. THE PATIENT HAD A PULSE OX OF 81% AT 0620 ON THE MONITOR AND A PULSE OX OF 81% AT 0720. THE PATIENT REQUIRED MEDICAL INTERVENTION OF INCREASED FIO2, BAG-VALVE-MANUAL VENTILATION AND BRONCHOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593181 M-LNCS ADTX OXIMETER DQA MASIMO CORPORATION 2508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention