BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOLL E-SERIES MONITOR/DEFIBRILLATOR

    MDR report key: 1202361 · Received October 10, 2008

    Report

    Report Number
    MW5008664
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    January 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    ZOLL MEDICAL PRODUCTS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MED 5 RESPONDED TO A PATIENT IN CARDIAC ARREST. INITIAL RHYTHM WAS NOTED TO BE ASYSTOLE, AS MONITORED THROUGH THE DEFIBRILLATOR PADS. RESUSCITATION ATTEMPT WAS INITIATED. AFTER TWO ROUNDS OF EPINEPHRINE AND ATROPINE, THE PATIENT REGAINED PULSES. ECG STILL SHOWED PATIENT TO BE IN ASYSTOLE, SO THE CREW TURNED UP THE GAIN, WITH NO RESULTS. ECG ELECTRODES WERE ATTACHED TO MONITOR THE RHYTHM THROUGH THE INDIVIDUAL LEADS. ALL LEADS SHOWED ASYSTOLE IN A PULSATILE PATIENT. ALL CABLES AND CONNECTIONS WERE CHECKED AND FOUND TO BE SECURE. PATIENT WAS TRANSPORTED WITH PULSES, BUT EXPIRED IN THE ED. MONITOR/DEFIBRILLATOR WAS TURNED INTO MILWAUKEE COUNTY EMS FOR RETURN TO THE MANUFACTURER. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL E-SERIES MONITOR/DEFIBRILLATOR MONITOR/DEFIBRILLATOR MKJ ZOLL MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other