BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS

    MDR report key: 1590780 · Received January 26, 2010

    Report

    Report Number
    MW5014545
    Event Type
    Death
    Date Received
    January 26, 2010
    Date of Event
    November 30, 2009
    Report Date
    January 26, 2010
    Manufacturer
    PHILIPS ELECTRONICS NORTH AMERICA CORP.
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ALARMING MECHANISM ON A PHILIPS PT CARE MONITOR AND OXIMETER PULSE-OX SYSTEM, WHILE IN USE ON PT, MAY NOT HAVE ALARMED WHILE THE PT'S HEART RATE AND OXYGEN SATURATION LEVELS WERE DECLINING. THE PT EXPIRED WITHIN 6 DAYS OF THE ABOVE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MONITOR MHX PHILIPS ELECTRONICS NORTH AMERICA CORP. MP-50

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death