BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9349711 · Received November 20, 2019

    Report

    Report Number
    3008642652-2019-09360
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    October 22, 2019
    Report Date
    November 19, 2019
    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

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. DEVICE EVALUATION SUMMARY: THE MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAVE BEEN RETURNED TO THE DISTRIBUTOR AND INVESTIGATION IS UNDERWAY. DEVICE EVALUATION INCLUDES 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 TREATMENT. MANUFACTURE DATE MONITOR - (B)(4) - 4/8/2014, BELT - (B)(4) - 3/26/2014. ROOT CAUSE: THE INVESTIGATION INTO THE EVENT CONCLUDES THAT THERE WAS NO DEVICE MALFUNCTION. A CAUSE AND EFFECT ANALYSIS WAS CONDUCTED USING ALL OF THE AVAILABLE INFORMATION WHICH INCLUDES THE INCIDENT REPORT, DEVICE EVALUATION, SOFTWARE FLAG FILES, AND ECG STRIPS. THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS LACK OF RESPONSE BUTTON USE PRIOR TO SHOCK DELIVERY. THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS MOTION ARTIFACT. THE SOURCE OF THE MOTION ARTIFACT COULD NOT BE POSITIVELY IDENTIFIED THROUGH THE CAUSE AND EFFECT ANALYSIS. THE FOLLOWING FACTORS COULD NOT BE RULED OUT AS CONTRIBUTING CAUSES OF THE MOTION ARTIFACT: BODY MOTION, POOR ECG CONTACT WITH SKIN. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. (B)(4). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030B.PDF. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF ONE SHOCK. IT WAS REPORTED THAT THE PATIENT WAS CONSCIOUS AT THE TIME OF THE EVENT. THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT EVENT. THERE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND THE PATIENT CONTINUES TO WEAR THE LIFEVEST. THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144843 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other