BEUDAMED
    FDA Adverse Event Death Summary report: N

    LNCS ADTX

    MDR report key: 3873838 · Received June 4, 2014

    Report

    Report Number
    2031172-2014-00064
    Event Type
    Death
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K060143
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE CUSTOMER "WE HAD ANOTHER INCIDENT RECENTLY WHERE A PROBE WAS READING HIGH (20%) VS ABG. THE PT HAS AN PAO2 OF 36 AND SPO2 OF 75% (ART LINE - YES). A SECOND PROBE WAS USED ALTERNATE SIGHT - AND TRANSIENTLY READ ACCURATELY LOW (FOR ABOUT 10-15 MINS) THEN REVERTED TO A HIGH SPO2 (AGAIN RE-CONFIRMED WITH ABG). WE THEN TRIED THE FOREHEAD PROBE WHICH DID THE SAME. AN INCIDENT REPORT WAS FILED AND (B)(6) WAS CHECKING OUT THE CABLE TO MAKE SURE NOT AN EQUIPMENT ISSUES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327504 LNCS ADTX DQA MASIMO CORPORATION LNCS ADTX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death VENTILATOR