BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4824068 · Received June 4, 2015

    Report

    Report Number
    3008642652-2015-03649
    Event Type
    Death
    Date Received
    June 4, 2015
    Date of Event
    April 20, 2015
    Report Date
    June 3, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ELECTRODE BELT SN (B)(4) HAS NOT BEEN RETURNED FOR INVESTIGATION. DEVICE EVALUATION OF MONITOR SN (B)(4) WAS COMPLETED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO PRODUCE A DRIVEN GROUND SIGNAL. THE CAUSE FOR THE FAILURE WAS AN OPEN R781 DRIVEN GROUND RESISTOR ON THE C/A BOARD. THE ROOT CAUSE FOR THE OPEN RESISTOR AS THE EXTERNAL DEFIBRILLATION DELIVERED WHILE THE LIFEVEST WAS ACTIVELY MONITORING THE PATIENT. THERE IS NO INDICATION THAT THE MONITOR MALFUNCTIONED DURING PATIENT USE. THERE IS NO EVIDENCE TO SUGGEST THAT THE OPEN RESISTOR CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. MONITOR SN (B)(4): 03/2012. ELECTRODE BENT SN (B)(4): 10/2013.

    Description of Event or Problem · 1

    A DISTRIBUTOR NOTIFIED ZOLL THAT A (B)(6) FEMALE PATIENT PASSED AWAY ON (B)(6) 2015 WHILE IN THE HOSPITAL. VENTRICULAR FIBRILLATION (VF) WAS DETECTED AT 13:53:05 ON (B)(6) 2015. THE LIFEVEST DELIVERED A 150J PULSE AT 13:53:39 AND CONVERTED THE ARRHYTHMIA TO SINUS BRADYCARDIA. ANOTHER ARRHYTHMIA (CPR ARTIFACT WITH VF) WAS DETECTED AT 20:08:29. A NON-LIFEVEST EXTERNAL DEFIBRILLATION CONVERTED THE VF TO SINUS TACHYCARDIA. CPR ARTIFACT INTERFERED WITH THE LIFEVEST DETECTION AN TREATMENT OF THE ARRHYTHMIA. THE LIFEVEST DETECTED FOUR ADDITIONAL ARRHYTHMIAS BETWEEN 20:10:52 AND ENDING AT 20:21:49. THE PATIENT'S ECG SHOWS CPR ARTIFACT AND A SINUS RHYTHM DURING THESE ARRHYTHMIA DETECTING. THE RHYTHM THEN TRANSITIONED TO VF FOUR SECONDS PRIOR TO LIFEVEST DEACTIVATION. THE LIFEVEST WAS SHUTDOWN AT 20:23:07.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363763 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death