BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 2033276 · Received March 18, 2011

    Report

    Report Number
    2033276
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    December 15, 2010
    Report Date
    March 18, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FACILITY OWNED AMBULANCE SERVICE RESPONDED TO A CALL OF A CARDIAC ARREST OF A CHILD. THE PATIENT WAS INTUBATED AND DEFIBRILLATOR WAS PROPERLY CONNECTED TO THE PATIENT AND THE PARAMEDICS DISCOVERED THAT THE END TIDAL CARBON DIOXIDE (ETCO2) FEATURE WAS NOT FUNCTIONING. THE ETCO2 DATA WOULD NOT DISPLAY. THE PARAMEDICS USED THE FIRE DEPARTMENT'S END TIDAL CO2 EVALUATION DEVICE (COLORIMETRIC). THE DEFIBRILLATOR WAS PULLED FROM SERVICE AND SENT TO THE BIOMEDICAL ENGINEERING DEPARTMENT FOR AN EVALUATION. BIOMED VERIFIED THAT THE ETCO2 DATA WAS NOT FUNCTIONING AND "CHECK CO2 ADAPTER" WAS DISPLAYED. THE BIOMED TECHNICIAN REPLACED THE ETCO2 ADAPTER AND THE DEFIBRILLATOR PASSED ALL CHECKS. THE UNIT WAS PLACED BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR, EXTERNAL MKJ ZOLL MEDICAL CORPORATION M SERIES W/ETCO2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR