BEUDAMED
    FDA Adverse Event Death Summary report: N

    LNC MP10

    MDR report key: 4340009 · Received December 5, 2014

    Report

    Report Number
    2031172-2014-00498
    Event Type
    Death
    Date Received
    December 5, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K051212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVAL OR NEW INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCIDENT IN THEIR ICU. PT SATURATION ON THE MONITOR WAS IN THE 70'S BUT THE PT PRESENTED DIFFERENTLY. A DOCTOR WAS AT THE BEDSIDE AND REQUESTED AN ABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786302 LNC MP10 OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ROTOPRONE BED| PHILIPS MP70| MASIMO ADHESIVE SENSOR| PHILIPS MMS MODULE