BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6831571 · Received August 30, 2017

    Report

    Report Number
    3008642652-2017-07268
    Event Type
    Death
    Date Received
    August 30, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 29, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) WAS COMPLETED. 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 MONITOR MALFUNCTION. THE ELECTRODE BELT SN (B)(4) HAS NOT YET BEEN RECOVERED FROM THE FIELD. A REVIEW OF THE PATIENT'S DOWNLOADED SOFTWARE FLAG FILES AND ECG RECORDINGS. THE SOFTWARE FLAG FILES DO NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE INAPPROPRIATE TREATMENT EVENT. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 02/06/2015, ELECTRODE BELT SN (B)(4): 03/21/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY IN A HOSPITAL. IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT PASSED AWAY ON (B)(6) 2017 AT 2:15PM WHILE WEARING THE LIFEVEST. THE PATIENT'S DAUGHTER REPORTED THAT THE PATIENT'S DEATH WAS CARDIAC RELATED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS ALARMING AT THE TIME OF THE PATIENT PASSING AND THAT HOSPITAL STAFF PRESENT WERE PERFORMING CPR. THE PATIENT'S DAUGHTER STATED THAT THE PATIENT MAY HAVE BEEN TREATED BY THE LIFEVEST PRIOR TO PASSING. A REVIEW OF THE PATIENT'S DOWNLOADED FLAG FILES AND ECG RECORDINGS REVEALED THAT THE PATIENT RECEIVED AN INAPPROPRIATE DEFIBRILLATION ON (B)(6) 2017. AT 14:11:19 TO 14:17:22 ON (B)(6) 2017, THE LIFEVEST DETECTED ASYSTOLE. THE ECG RECORDINGS SHOW THE PATIENT WAS IN SEVERE BRADYCARDIA AT 10 BPM DEGRADING TO ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY AND CPR ARTIFACT. AT 14:28:16 ON (B)(6) 2017, THE PATIENT WAS TREATED BY THE LIFEVEST. THE RHYTHM AT THE TIME OF THE TREATMENT WAS ASYSTOLE WITH CPR ARTIFACT. THE POST-SHOCK RHYTHM WAS ASYSTOLE WITH CPR ARTIFACT. THE CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. ASYSTOLE IS CONSIDERED TO BE A NON-SHOCKABLE RHYTHM. THE LIFEVEST WAS REMOVED ON (B)(6) 2017 AT 15:36:48. MULTIPLE ATTEMPTS TO DETERMINE THE EXACT DETAILS SURROUNDING THE PATIENT DEATH WERE UNSUCCESSFUL. THE EXACT DATE OF THE PATIENT'S DEATH IS NOT KNOWN. THERE IS NO EVIDENCE TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, AS THE PATIENT WAS ALREADY IN A NON-TREATABLE, NON-LIFE SUSTAINING RHYTHM PRIOR TO THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612167 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death