BEUDAMED
    FDA Adverse Event Death Summary report: N

    AEDEFIBRILLATOR2

    MDR report key: 572741 · Received February 11, 2005

    Report

    Report Number
    572741
    Event Type
    Death
    Date Received
    February 11, 2005
    Date of Event
    January 31, 2005
    Report Date
    February 10, 2005
    Manufacturer
    MRL, INC. (A WELCH ALLYN CO)
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESCUERS ATTEMPTED TO USE AED ON COLLAPSED PT WHO QUICKLY BECAME APNEIC AND PULSELESS. AED WAS APPLIED WITHIN 5-7 MINUTES. FROM REPORTS FROM THE RESUCERS AND FURTHER INVESTIGATION, IT APPEARS THE DEVICE HAD BEEN INADVERTENTLY MISCONFIGURED INTO THE EMS ON MODE (MANUAL) RATHER THAN THE EMS OFF MODE (AUTOMATIC) THAT THE RESCUERS WERE TRAINED IN. THE RESCUERS DID NOT GET THE VERBAL CUES THEY EXPECTED AND NO SHOCK WAS ADMINISTERED. THEY DID NOT KNOW HOW TO INTERPRET THE "CHECK PATIENT" CUE, DID NOT PUSH THE LCD DIRECTED VISUAL INSTRUCTION TO "ANALYZE", AND SINCE THEY DID NOT REALIZE THE AED WAS IN THE EMS ON MODE, THEY DID NOT KNOW THEY NEEDED TO REPROGRAM IT TO EMS OFF MODE (THE MODALITY THEY WERE TRAINED). FROM THE PROMPT GIVEN ("CHECK PATIENT"), THE TEXT IN THE AED MANUAL, AND TESTS CO DID, IT IS HIGHLY PROBABLE THE VICTIM HAD A SHOCKABLE RHYTHM. CO IS AWAITING SOFTWARE AND COMMUNICATION CABLES TO INTERROGATE THE AED TO SEE IF CO CAN IDENTIFY THE SPECIFIC CARDIAC RHYTHM.

    Description of Event or Problem · 1

    PRELIMINARY AUTOPSY INFORMATION WAS THE HEART WAS GROSSLY NORMAL EXCEPT FOR A SHORT SEGMENT OF MID LAD RUNNING INTRAMYOCARDIALLY. THERE WAS NO EVIDENCE OF DILATED OR OBSTRUCTIVE CARDIOMYOPATHY OR VALVULAR HEART DISEASE. FINAL PATHOLOGY IS PENDING. MODEL AEDEFIBRILLATOR 2, PART # 970214E, MANUFACTURED BY MEDICAL RESEARCH LABORATORIES, INC. PROBLEM: THIS DEVICE CAN BE INADVERTENTLY MISCONFIGURED IN AN UNINTENDED MODE OF OPERATION RESULTING IN CONFUSION FOR THE USER IN AN EMERGENCY SITUATION. THE "FREQUENT USE" OPERATOR'S CHECKLIST TELLS THE USER TO ENTER MANUAL OVERRIDE MODE (EMS ON). THIS MODEL DOES NOT HAVE A MANUAL MODE. IT HAS AN EMS ON OR EMS OFF MODE. THERE IS THE POTENTIAL FOR THIS PARTICULAR MODEL TO BE INADVERTENTLY LEFT IN THE EMS ON MODE, RESULTING IN CONFUSION. THIS MODEL WILL NOT REVERT TO THE AUTOMATIC MODE AS DO PREVIOUS VERSIONS OF THIS DEVICE. DISCUSSION: THIS UNIT CAN BE OPERATED IN THE EMS ON OR THE EMS OFF MODE. THIS OPERATIONAL SELECTION REQUIRES ENTRY OF A CODE AFTER ACCESSING THE SETUP MENU. WHEN THE UNIT IS INITIALLY TURNED ON, IT RUNS A SELF-TEST AND MOMENTARILY DISPLAYS ITS CURRENT SETUP MODE. IN THE EMS ON MODE, THE UNIT WILL PROVIDE AN AUDIA PROMPT TO ATTACH THE PATIENT CABLE AND PADS. THE LCD PANEL DISPLAYS PRESS TO ANALYZE BUT PROVIDES NO FURTHER AUDIO PROMPTS. IF THE PATIENT HAS A NORMAL SINUS RHYTHM (NSR), THE UNIT DISPLAYS MONITORING ECG, PRESS TO ANALYZE WITH NO AUDIO PROMPT. THE UNIT WILL SOUND 2 BEEPS AT THE ONE MINUTE MARK AND CONTINUE TO BEEP TWICE AT ONE-MINUTE INTERVALS. IF THE PATIENT IS IN VFIB, AFTER 12 SECONDS OF MONITORING, THE UNIT WILL PROVIDE AN AUDIO PROMPT OF CHECK PATIENT WHILE DISPLAYING PRESS TO ANALYZE. IT WILL CONTINUE THIS AT 12 SECOND INTERVALS. IN THE EMS OFF MODE, THE SAME INITIAL PROMPT TO ATTACH CABLE AND PADS IS GIVEN. WITH A NSR, THE UNIT GIVES BOTH AN AUDIO PROMPT AND A VISUAL DISPLAY OF ANALYZING. IT WILL CONTINUE TO GIVE AUDIO INSTRUCTIONS AS APPROPRIATE. IF THE PATIENT IS IN VFIB, THE UNIT WILL GIVE THE AUDIO AND VISUAL PROMPTS OF ANALYZING WITH ADDITIONAL INSTRUCTIONS. IT WILL ADVISE THE USER TO SHOCK WITH AN AUDIO AND VISUAL PROMPT OF SHOCK ADVISED. THIS WILL BE FOLLOWED BY AN AUDIO AND VISUAL PROMPT OF SHOCK NOW. THE UNIT WILL SOUND A CONTINUOUS ON/OFF BEEPING, ILLUMINATE THE RED SHOCK BUTTON, AND PROVIDE VOICE INSTRUCTION TO SHOCK. AFTER THE SHOCK IS DELIVERED, THE UNIT REPEATS THE ANALYZING PROCESS. THE LCD DISPLAY USED BY THIS UNIT CAN BE DIFFICULT TO SEE EVEN WITH THE USER ADJUSTABLE CONTRAST SET FOR THE BEST VIEWING. THE BUTTONS USED TO INPUT THE SETUP MENU ACCESS CODE ARE MEMBRANE-TYPE SWITCHES THAT ARE THE SAME COLOR AS THE BODY OF THE UNIT AND ARE NOT READILY VISIBLE. IF THE UNIT IS MISTAKENLY SETUP IN THE WRONG MODE, A USER COULD BECOME CONFUSED BY THE DEVICE NOT OPERATING AS EXPECTED, AND WITHOUT THE ACCESS CODE, THEY WOULD BE UNABLE TO CHANGE THE UNIT TO THE DESIRED MODE. CONFUSION CAN ALSO ARISE FROM THE OPERATOR'S CHECKLIST IN THE USER'S MANUAL. THE USER'S MANUAL HAS TWO OPERATOR'S CHECKLISTS, ONE FOR "INFREQUENT USE" AND ONE FOR "FREQUENT USE". THE APPROPRIATE CHECKLIST IS DETERMINED BY THE TYPE OF BATTERY USED TO POWER THE DEFIBRILLATOR. RECHARGEABLE BATTERY-POWERED UNITS ARE TO USE THE "FREQUENT USE" CHECKLIST, NON-RECHARGEABLE BATTERY-POWERED UNITS USE THE "INFREQUENT USE" CHECKLIST. SINCE THE DEFIBRILLATOR CAN USE EITHER TYPE OF BATTERY, AND THE CHECKLISTS HAVE DIFFERENT REQUIREMENTS, A SECTION WITH BOTH TYPES OF BATTERIES COULD BE PERFORMING DIFFERENT OPERATOR'S CHECK ON THE SAME UNITS IN THEIR DEPARTMENT. RECOMMENDATIONS/ACTION NEEDED: RECOMMEND A ONE TIME INSPECTION OF ALL DEVICES TO ENSURE THEY ARE IN THE EMS OFF MODE (AUTOMATIC). THE CURRENT CHECKLIST ON PAGE 4-10 IN MANUAL 990020 - REV F SHOULD HAVE AN ITEM I. ADDED. "RETURN DEVICE TO THE INTENDED MODE OF OPERATION. WARNING - THIS DEVICE MUST BE RETURNED TO THE EMS OFF MODE. IT DOES NOT DEFAULT TO THE EMS OFF MODE WITH POWER DOWN. IT REQUIRES SELECTION ON THE MENU AND REENTRY OF THE SUPERVISOR PASSCODE. IN ADDITION, RECOMMEND THAT THE DEFAULT CODE BE RESET DURING THE ONE TIME INSPECTION TO ANOTHER CODE TO PREVENT UNAUTHORIZED MODE CHANGES. THE OPERATOR'S CHECKLISTS NEED TO BE WRITTEN FOR EACH SPECIFIC MODEL/REVISION AND HAVE THEIR FREQUENCY DETERMINATION MORE CLEARLY DEFINED. THE LCD DISPLAY SHOULD BE IMPROVED OR REPLACED WITH A MORE CLEARLY VISIBLE DISPLAY. THE MENU SELECTION BUTTONS SHOULD BE A DIFFERENT COLOR THAN THE MAIN BODY OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEDEFIBRILLATOR2 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ MRL, INC. (A WELCH ALLYN CO) AEDEFIBRILLATOR *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death