BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS OXIMETRY SENSORS

    MDR report key: 3660037 · Received February 21, 2014

    Report

    Report Number
    2031172-2014-00012
    Event Type
    Other
    Date Received
    February 21, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K041815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AS WELL AS ADDITIONAL INFO REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE SENSOR INVOLVED IN THE REPORTED EVENT AND CONDUCT AN ANALYSIS. THE CUSTOMER INDICATED THAT THEY NO LONGER HAVE THE PRODUCT AND THAT PT RELATED REVIEW. IF NEW INFO IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER SITE INDICATED THAT THEY HAD RECEIVED REPORTS OF PT BURNS WHEN USING THE SENSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111606 LNCS OXIMETRY SENSORS DQA MASIMO CORPORATION NEO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other