BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6027088 · Received October 13, 2016

    Report

    Report Number
    3008642652-2016-07514
    Event Type
    Death
    Date Received
    October 13, 2016
    Date of Event
    August 31, 2016
    Report Date
    September 7, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 OF MONITOR 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 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)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO TRUNK CABLE CONNECTOR J702 ON THE DISTRIBUTION NODE PCA. THE J702 CONNECTOR WAS PHYSICALLY PULLED FROM THE PCA. A REVIEW OF DOWNLOAD DATA SUGGESTS THAT THE DAMAGE OCCURRED WHILE EMS WAS REMOVING THE DEVICE TO PERFORM RESUSCITATION ATTEMTPS. THERE IS NO INDICATION THAT THE DAMAGED CABLE CAUSED OR CONTRIBUTED TO THE DEATH.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. DURING THE INCOMING FUNCTIONAL TESTING, A 1 HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, FOLLOWED BY A 5 HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5 HZ 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)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO TRUNK CABLE CONNECTOR J702 ON THE DISTRIBUTION NODE PCA. THE J702 CONNECTOR WAS PHYSICALLY PULLED FROM THE PCA. A REVIEW OF DOWNLOAD DATA SUGGESTS THAT THE DAMAGE OCCURRED WHILE EMS WAS REMOVING THE DEVICE TO PERFORM RESUSCITATION ATTEMPTS. THERE IS NO INDICATION THAT THE DAMAGED CABLE CAUSED OR CONTRIBUTED TO THE DEATH.

    Description of Event or Problem · 1

    A DISTRIBUTOR CONTACTED ZOLL TO REPORT A PATIENT DEATH. THE PATIENT PASSED AWAY ON (B)(6) 2016 BETWEEN 6:30 AND 07:00 AM WHILE WEARING THE LIFEVEST. EMERGENCY SERVICES WAS CALLED TO THE PATIENT'S HOME WHERE CPR WAS INITIATED. INVESTIGATION INTO THE ECG RECORDINGS IS UNDERWAY WITH A SUPPLEMENTAL MDR TO BE SENT UPON COMPLETION.

    Description of Event or Problem · 1

    FOLLOW-UP REPORT #1: ADDITIONAL INFORMATION - 09/07/2018. THE INVESTIGATION INTO THE ECG RECORDINGS WAS COMPLETED. THE PATIENT WAS IN BRADYCARDIA BEFORE DEGRADING TO VF. THERE WERE ISOLATED, IRREGULAR QRS COMPLEXES DURING THE RUN OF VF. THE LIFEVEST DETECTED THE VF BUT DID NOT DELIVER A TREATMENT. AT 03:54:36 THE THERAPY ELECTRODES AND ECG ELECTRODES LOST CONTACT WITH THE PATIENT'S BODY, LIKELY INDICATING THE INITIATION OF RESUSCITATION ATTEMPTS. THE PATIENT WAS IN BRADYCARDIA FOR APPROXIMATELY TEN MINUTES PRIOR TO DEGRADING TO VF. THE LIFEVEST DETECTED THE BRADYCARDIA. AFTER DECLARING BRADYCARDIA, THE LIFEVEST DETECTION ALGORITHM LOOKS FOR FIVE CONSECUTIVE QRS BEATS AT OR ABOVE 40 BPM TO DECLARE A NORMAL RHYTHM. THE PATIENT DID NOT HAVE FIVE CONSECUTIVE QRS BEATS DURING THE EVENT. DUE TO THE IRREGULAR AND ISOLATED QRS COMPLEXES DURING THE RUN OF VF, THE QRS RATE DETECTOR HAD LOW CONFIDENCE, WHICH INCREASED THE AMOUNT OF TIME FOR THE ALGORITHM TO GAIN SUFFICIENT CONFIDENCE TO DECLARE A TREATABLE ARRHYTHMIA. THE LIFEVEST DID DETECT THE VF ARRHYTHMIA, BUT ECG AND THERAPY ELECTRODE FALL-OFF PREVENTED THE LIFEVEST FROM COMPLETING THE DETECTION AND TREATMENT SEQUENCE. THE LIFEVEST DID NOT MALFUNCTION DURING THE EVENT. A DISTRIBUTOR CONTACTED ZOLL TO REPORT A PATIENT DEATH. THE PATIENT PASSED AWAY ON (B)(6) 2016 BETWEEN 6:30 AND 07:00 AM WHILE WEARING THE LIFEVEST. EMERGENCY SERVICES WAS CALLED TO THE PATIENT'S HOME WHERE CPR WAS INITIATED. INVESTIGATION INTO THE ECG RECORDINGS IS UNDERWAY WITH A SUPPLEMENTAL MDR TO BE SENT UPON COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680213 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death