BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS OXIMETRY SENSORS

    MDR report key: 3683918 · Received February 28, 2014

    Report

    Report Number
    2031172-2014-00021
    Event Type
    Other
    Date Received
    February 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 30, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K041815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR THE RETURN OF THE SENSOR AS WELL AS ADDITIONAL INFORMATION REQUEST HAVE BEEN MADE IN ORDER TO IDENTIFY THE SENSOR INVOLVED IN THE REPORTED EVENT. THE CUSTOMER INDICATED THAT THE SENSOR WOULD BE RETURNED. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED BY MASIMO TO ALLOW FOR 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 TRACKS WERE SEEN ON THE PATIENT'S FINGER OR EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125020 LNCS OXIMETRY SENSORS DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other