BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL MEDICAL CORP

    MDR report key: 967403 · Received December 30, 2005

    Report

    Report Number
    967403
    Event Type
    Death
    Date Received
    December 30, 2005
    Date of Event
    April 19, 2007
    Report Date
    May 2, 2007
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT FOUND PULSELESS AND UNRESPONSIVE IN ROOM. FULL CODE INITIATED. ZOLL MONITOR STAT PADS APPLIED TO PATIENT, LEAD SELECTION CHECKED AND THE SETTING WAS ON PADS. ERROR MESSAGE RECEIVED "DEFIB PAD SHORT". CPR WAS CONTINUED WHILE THE MONITOR WAS CHANGED TO LEAD SETTING FOR MANUAL ATTEMPT TO IDENTIFY HEART RHYTHM. HEART RHYTHM WAS ASYSTOLE. MD NOTIFICATION WAS TAKING PLACE DURING THIS PROCESS AND HE ORDERED FOR CPR TO BE TERMINATED. IT IS IMPORTANT TO NOTE THAT THIS DEFIBRILLATOR (DEFIB) IS TESTED DAILY BY CLINICAL STAFF USING THE MFR RECOMMENDED CLINICAL TESTING PROCEDURE, AND THAT WHILE IN THIS TEST MODE THERE IS NO INDICATION THAT THERE IS ANYTHING WRONG WITH THE UNIT. THIS DEFIBRILLATOR DISPLAYS "TEST PASSED" EVERY TIME THE TEST PROCEDURE IS INITIATED. NOT UNTIL AN ACTUAL EMERGENCY SITUATION DID STAFF FIND OUT THE UNIT WAS NOT WORKING. IT IS NORMAL FOR THE DEFIB TO DISPLAY THE MESSAGE "DEFIB PAD SHORT" WHILE IN TEST MODE, BECAUSE THE PAD LEADS ARE PLUGGED INTO A SHORTING RECEPTACLE, THEN FIRED AT 30 JOULES INTO AN INTERNAL LOAD, BUILT INTO THE DEFIB. THERE WAS NO INDICATION OF A PROBLEM WITH THIS DEFIB UNTIL UNIT WAS CONNECTED TO THE PATIENT, AND TURNED ON. AT THIS POINT THE MESSAGE "DEFIB PAD SHORT" WAS DISPLAYED ON THE SCREEN, EVEN THOUGH LEADS WERE NOT PLUGGED INTO THE SHORTING RECEPTACLE, AND DEFIB WOULD NOT DISCHARGE ENERGY INTO PATIENT WHEN ATTEMPTED. IT IS ALSO IMPORTANT TO NOTE THAT THIS IS NOT THE FIRST TIME CLINICAL ENGINEERING DEPT HAS SEEN THIS PROBLEM. WE CAME ACROSS AN M-SERIES DEFIB WITH THE SAME PROBLEM IN 2004 WHILE PERFORMING CONTRACTED ROUTINE PREVENTIVE MAINTENANCE (PM) AT ANOTHER HOSPITAL IN OUR REGION. IT PRESENTED WITH THE SAME SYMPTOMS OF PASSING THE 30-JOULE SELF TEST, BUT WHEN ACTUAL OUTPUT WAS TESTED WE HAD THE SAME "PADS SHORTED" MESSAGE WITH NO OUTPUT - UNIT WOULD NOT FIRE AT ANY OTHER SETTING. THERE WAS NO PATIENT INCIDENT INVOLVED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORP DEFIBRILATOR MKJ ZOLL MEDICAL CORP M SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death