BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE, MP70

    MDR report key: 2102998 · Received May 16, 2011

    Report

    Report Number
    2102998
    Event Type
    Death
    Date Received
    May 16, 2011
    Date of Event
    March 12, 2009
    Report Date
    March 29, 2009
    Manufacturer
    PHILLIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS FOUND EXPIRED WITH LEADS SECURED TO THE PATIENT BUT NO AUDIBLE OR VISUAL ALARMS WERE ACTIVATED. THE NURSE CHECKED FOR LEAD PLACEMENT AND WAS CERTAIN THE LEADS WERE SECURELY ATTACHED BUT THAT THE ALARMS DID NOT SOUND UNTIL SHE TAPPED ON THE HEART MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE, MP70 MONITOR, PHYSIOLOGICAL MHX PHILLIPS MEDICAL SYSTEMS MP70 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death NO OTHER THERAPIES