BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10619383 · Received October 2, 2020

    Report

    Report Number
    3008642652-2020-08601
    Event Type
    Injury
    Date Received
    October 2, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 2, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. DEVICE EVALUATION SUMMARY DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO COMMUNICATE WITH AN ELECTRODE BELT. THE MONITOR'S ELECTRODE BELT CONNECTOR WAS BROKEN FREE FROM THE MONITOR ENCLOSURE, DAMAGING WIRES WITHIN THE CONNECTOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR WAS EXCESSIVE FORCE. THE DEVICE IS DESIGNED TO MEET IEC 60601-1 MECHANICAL REQUIREMENTS. PER THE ATTACHED DOWNLOAD DATA, THE DAMAGE TO THE MONITOR DID NOT OCCUR PRIOR TO THE TREATMENT EVENT, AND THE DAMAGE DID NOT CAUSE OR CONTRIBUTE TO THE TREATMENT EVENT. THE DAMAGE TO THE MONITOR OCCURRED AT SOME POINT AFTER THE TREATMENT EVENT. CORRECTIVE ACTION: SEE CAR-1332 A DESIGN CHANGE TO ADDRESS THIS CONDITION (PMA SUPPLEMENT P010030/S138) WAS APPROVED BY FDA ON 08/04/2020. ELECTRODE BELT SN (B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR, IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY ZOLL MANUFACTURING CORPORATION. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. 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 INAPPROPRIATE TREATMENT. 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. THE INVESTIGATION INTO THE EVENT CONCLUDES THAT THERE WAS NO DEVICE MALFUNCTION. A CAUSE AND EFFECT ANALYSIS WAS CONDUCTED (ATTACHED) USING ALL OF THE AVAILABLE INFORMATION WHICH INCLUDES THE INCIDENT REPORT, DEVICE EVALUATION, SOFTWARE FLAG FILES (ATTACHED), AND ECG STRIPS . THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS LACK OF RESPONSE BUTTON USE PRIOR TO THE TREATMENT SHOCK (PATIENT ERROR). THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS SVT. THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. 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. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL (B)(4) (0.69%PER PATIENT-MONTH WITH 90% CONFIDENCE). 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. NO DETAILS SURROUNDING THE EVENT WERE REPORTED. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE TREATMENT EVENT. SUPRAVENTRICULAR TACHYCARDIA (SVT) CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND CONTINUED USE OF THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085344 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other