BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHYSIO-CONTROL, INC LIFEPAK 12 MONITOR

    MDR report key: 1420990 · Received July 21, 2009

    Report

    Report Number
    MW5012074
    Event Type
    Death
    Date Received
    July 21, 2009
    Date of Event
    July 14, 2009
    Report Date
    July 21, 2009
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EMS SERVICE PROVIDED ACLS FOR CARDIAC ARREST OF THIS PT WITH A LIFEPAK12. INITIALLY WAS ABLE TO MANUALLY DEFIB PT. AFTER 2 SHOCKS THE LIFEPAK WOULD NO LONGER MANUALLY SHOCK PT. NEW PADS AND ALL CONNECTIONS CHECKED AND REATTEMPTED WITHOUT SUCCESS. SWITCHED TO ADVISORY MODE AND WAS ABLE TO DEFIB IN THIS MODE. DATES OF USE: 2004 - 2009. DIAGNOSIS OR REASON FOR USE: #1. CARDIAC MONITORING. #2. CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO-CONTROL, INC LIFEPAK 12 MONITOR LIFEPAK12 LDD PHYSIO-CONTROL, INC. UVLP12029010

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death