BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL MEDICAL CORP.

    MDR report key: 1360351 · Received April 9, 2009

    Report

    Report Number
    MW5010706
    Event Type
    Death
    Date Received
    April 9, 2009
    Date of Event
    April 8, 2009
    Report Date
    September 14, 2007
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING RESUSCITATION OF PATIENT IN CARDIAC ARREST ZOLL E SERIES MONITOR INITIALLY PROVIDED EKG TRACING AND DEFIB CAPABILITY. APPROXIMATELY 3 MINUTES INTO THE RESUSCITATION MONITOR EKG STOPPED PROVIDING EKG TRACING. THE UNIT STILL HAD BATTERY POWER. UNIT ALSO HAD ETCO 2 MONITOR IN PLACE WHICH FAILED TO ZERO AND WOULD NOT PROVIDE WAVE FORM TRACING. THE RESCUE CREW ATTEMPTED TO POWER DOWN AND RESTART MONITOR WITHOUT CHANGE TO THE SYSTEM. PATIENT DID NOT SURVIVE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORP. E SERIES CARDIAC MONITOR MKJ ZOLL MEDICAL CORP. E SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death