BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL MFG

    MDR report key: 1456276 · Received April 13, 2009

    Report

    Report Number
    1456276
    Event Type
    Death
    Date Received
    April 13, 2009
    Date of Event
    April 10, 2009
    Report Date
    April 13, 2009
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE RESUSCITATION OF A FEMALE UNDER CPR, THE PATIENT WAS INTUBATED VIA ETI. THE CAPNOSTAT 5 MAINSTREAM ETCO2 DETECTOR ATTACHED TO THE E SERIES MONITOR WAS ATTACHED TO THE PATIENT'S AIRWAY. THE ETCO2 DETECTOR WAS NOT ABLE TO CAPTURE A WAVEFORM AFTER THE WARM UP PHASE OF THE DEVICE. THE DEVICE CONNECTION WAS CHECKED WITH NO RESULTANT CHANGE IN OPERATION. THIS PATIENT DID EXPIRE DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MFG CAPNOSTAT 5 MAINSTREAM ETCO 2 CCK ZOLL MEDICAL CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death