BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL MFG

    MDR report key: 1490759 · Received September 23, 2009

    Report

    Report Number
    1490759
    Event Type
    Death
    Date Received
    September 23, 2009
    Date of Event
    September 17, 2009
    Report Date
    September 23, 2009
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    CCK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT LISTED ABOVE CALLED 911 FOR A MEDICAL COMPLAINT OF HEADACHE AND DIFFICULTY BREATHING. CREWS ARRIVED TO FIND A PT WHO WAS CONSCIOUS. PT RAPIDLY DETERIORATED AND WENT INTO CARDIAC ARREST. IT WAS PROVIDED IMMEDIATE ADVANCED LIFE SUPPORT TREATMENTS INCLUDING AN ADVANCED AIRWAY. THE ZOLL E SERIES MONITOR WITH COPNOSTAT 5 (ETCO2 DETECTOR) WAS APPLIED TO PT. THE CAPNOSTAT 5 DEVICE FAILED TO "ZERO" OUT AND WOULD NOT PRODUCE A WAVEFORM FOR PT DOCUMENTATION. PT WAS TRANSPORTED TO EMERGENCY ROOM UNDER FULL CARDIAC RESUSCITATION EFFORTS WHERE HE WAS PRONOUNCED DEAD AT THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MFG CAPNOSTAT 5 ETCO2 DETECTOR CCK ZOLL MEDICAL CORP. CAPNOSTAT 5

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death