BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10990790 · Received December 11, 2020

    Report

    Report Number
    3008642652-2020-11003
    Event Type
    Death
    Date Received
    December 11, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 12/16/2020: DEVICE EVALUATION OF MONITOR SN: (B)(6) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE AUDIO MESSAGING AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE EVALUATION OF BELT SN: (B)(6) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF A FULL ENERGY 150J BIPHASIC PULSE. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. MONITOR SN: (B)(6) WAS RETURNED TO ZMC AND THE EVALUATION IS CURRENTLY UNDERWAY. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT DEATH. H4. DEVICE MANUFACTURER DATE, MONITOR: 04/21/2016, ELECTRODE BELT: 05/30/2018.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT 12/16/2020: ADDITIONAL CONTINUOUS ECG DATA IS AVAILABLE AND SHOWS THAT WHEN THE ARRYTHMIA WAS DETECTED AT 07:24:46, THE PATIENT WAS IN SUPRAVENTRICULAR TACHYCARDIA (SVT) AT 150 BPM WITH PVC'S DEGRADING TO VT FROM 190 BPM TO 200 BPM WITH MOTION ARTIFACT, CPR / MOTION ARTIFACT AND RESPONSE BUTTON USE. SVT WAS SEEN IN BETWEEN THE VT/VF FROM APPROXIMATELY 07:25:07 UNTIL 07:32:24. CPR / MOTION ARTIFACT PREVENTED THE LIFEVEST FROM TREATING THE PATIENT. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A GERMAN PATIENT PASSED AWAY IN THE MORNING ON (B)(6) 2020, WHILE WEARING THE LIFEVEST. THE PATIENT WAS AT HOME PRIOR TO PASSING. IT WAS REPORTED THAT THE LIFEVEST WAS ALARMING. THE PATIENT'S SPOUSE REPORTED THAT THEY CALLED EMERGENCY SERVICES BUT THEY WERE UNABLE TO HELP THE PATIENT WHEN THEY ARRIVED. IT WAS REPORTED THAT THE LIFEVEST WAS OPENED BY AN EMERGENCY PHYSICIAN. PER CLINICAL REVIEW OF THE AVAILABLE ECG DATA, AN ARRHYTHMIA WAS DETECTED AT 07:24:46 WITH THE RESPONSE BUTTONS BEING PRESSED INTERMITTENTLY ON (B)(6) 2020. ECG SHOWS VENTRICULAR TACHYCARDIA (VT) AT 190 BPM WITH MOTION ARTIFACT. IT IS UNCLEAR WHO WAS PRESSING THE RESPONSE BUTTONS DURING THIS TIME. AN ARRHYTHMIA WAS DETECTED FIVE TIMES FROM 07:33:13 TO 07:41:56. ECG SHOWS VT AT 200 BPM DEGRADING EVEN FURTHER TO VENTRICULAR FIBRILLATION (VF) WITH VARIABLE HEART RATE, VARYING AMPLITUDES, MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF. THE ELECTRODE BELT WAS DISCONNECTED AT 08:05:20 ON (B)(6) 2020. THE DEVICE PROPERLY DETECTED VT / VF. HOWEVER, RESPONSE BUTTON USE, VARIABLE HEART RATE, VARYING AMPLITUDES, MOTION ARTIFACT, AND ELECTRODE LEAD FALL OFF PREVENTED THE LIFEVEST FROM TREATING THE PATIENT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BELT SN (B)(4) HAS BEEN COMPLETED.  THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED.  DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF A FULL ENERGY 150J BIPHASIC PULSE. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION AND PULSE DELIVERY FUNCTIONALITY.  THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. MONITOR SN (B)(4) WAS RETURNED TO ZMC AND THE EVALUATION IS CURRENTLY UNDERWAY. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT DEATH. DEVICE MANUFACTURER DATE: MONITOR: 04/21/2016, ELECTRODE BELT: 05/30/2018.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) PATIENT PASSED AWAY IN THE MORNING ON (B)(6) 2020, WHILE WEARING THE LIFEVEST. THE PATIENT WAS AT HOME PRIOR TO PASSING. IT WAS REPORTED THAT THE LIFEVEST WAS ALARMING. THE PATIENT'S SPOUSE REPORTED THAT THEY CALLED EMERGENCY SERVICES BUT THEY WERE UNABLE TO HELP THE PATIENT WHEN THEY ARRIVED. IT WAS REPORTED THAT THE LIFEVEST WAS OPENED BY AN EMERGENCY PHYSICIAN.   PER CLINICAL REVIEW OF THE AVAILABLE ECG DATA, AN ARRHYTHMIA WAS DETECTED AT 07:24:46 WITH THE RESPONSE BUTTONS BEING PRESSED INTERMITTENTLY ON (B)(6) 2020. ECG SHOWS VENTRICULAR TACHYCARDIA (VT) AT 190 BPM WITH MOTION ARTIFACT. IT IS UNCLEAR WHO WAS PRESSING THE RESPONSE BUTTONS DURING THIS TIME. AN ARRHYTHMIA WAS DETECTED FIVE TIMES FROM 07:33:13 TO 07:41:56. ECG SHOWS VT AT 200 BPM DEGRADING EVEN FURTHER TO VENTRICULAR FIBRILLATION (VF) WITH VARIABLE HEART RATE, VARYING AMPLITUDES, MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF. THE ELECTRODE BELT WAS DISCONNECTED AT 08:05:20 ON (B)(6) 2020. THE DEVICE PROPERLY DETECTED VT/VF. HOWEVER, RESPONSE BUTTON USE, VARIABLE HEART RATE, VARYING AMPLITUDES, MOTION ARTIFACT, AND ELECTRODE LEAD FALL OFF PREVENTED THE LIFEVEST FROM TREATING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455692 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death