BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 PHYSIO CONTROL

    MDR report key: 337202 · Received June 11, 2001

    Report

    Report Number
    337202
    Event Type
    Death
    Date Received
    June 11, 2001
    Date of Event
    May 18, 2001
    Report Date
    June 4, 2001
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    POST SUCCESSFUL DEFIBRILLATION 200, 300, 3604. RHYTHM CONVERTED TO IDIOVENTRICULAR, ATTEMPTED TRANSCUTANEOUS CARDIAC PACEMAKER SUCCESSFUL FOR SEVERAL SECONDS WHEN MONITOR SCREEN SHOWING ONLY THREE DASHED ISOELECTRIC LINES. ALL LEADS CONNECTED TO PT TRANSCUTANEOUS CARDIAC PACEMAKER RESTARTED-MONITOR APPEARS TO NOT RECEIVE WAVEFORM FROM 4 LEAD (INTERMITTENT) RE-CHECKED ALL ELECTRODES, ALL FIRMLY ATTACHED TO PT CPR CONTINUED, HOWEVER ECG SHOWING ONLY WAVY BASE LINE OR DASHED LINES IN ALL LEADS I-II-III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26662 LIFEPAK 12 PHYSIO CONTROL CARDIAC MONITOR (LIFEPAK 12) LDD PHYSIO CONTROL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death