BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARQUETTE ELECTRONICS

    MDR report key: 60616 · Received January 6, 1997

    Report

    Report Number
    60616
    Event Type
    Death
    Date Received
    January 6, 1997
    Date of Event
    December 26, 1996
    Report Date
    December 27, 1996
    Manufacturer
    MARQUETTE ELECTRONICS
    Product Code
    DQK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MONITOR MALFUNCTIONED DURING ANGIOPLATY PROCEDURE. PT WAS IMMEDIATELY CONNECTED TO PORTABLE MONITORING DEVICE. BLOOD PRESSURE CONTINUED TO DROP ND CODE WAS CALLED. DURING THE PROCEDURE, PT WAS NOTED TO HAVE DISSECTION IN CIRCUMFLEX ARTERY AND TECHS WERE UNABLE TO VISUALIZE THE LEFT CORONARY ARTERY SYSTEM. THE PT WAS TAKEN TO SURGERY FOR EMERGENCY CORONARY ARTERY BYPASS WITH GRAFTS AND INTRA-AORTIC BALLOON PUMP INSERTION. THE PT EXPIRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE ELECTRONICS PATIENT MONITORING SYSTEM (COMPUTERIZED) DQK MARQUETTE ELECTRONICS MACLAB *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death