BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4688721 · Received April 10, 2015

    Report

    Report Number
    3008642652-2015-01730
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    February 12, 2014
    Report Date
    April 10, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    NVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PT RECEIVED A REPLACEMENT ELECTRODE BELT. THE PT ENDED USE ON (B)(6) 2014 BECAUSE THE PT RECEIVED AN ICD. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WERE COMPLETED. THE MONITOR AND ELECTRODE BELT WERE RETURNED AS ROUTINE MAINTENANCE AND FOUND TO BE FULLY FUNCTIONAL. ZOLL WAS UNAWARE OF THE TREATMENTS AND RESET THAT OCCURRED AT THAT TIME AND THEREFORE THERE WAS NO COMPLAINT WAS INITIALLY GENERATED. AN INVESTIGATION INTO MONITORS EXHIBITING THE SAME ISSUE FOUND THAT THE ROOT CAUSE FOR THE RESET IS NOISE FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. A REAL-TIME REVIEW REQUEST FOR A DESIGN CHANGE TO ADDRESS THIS ISSUE WAS SUBMITTED TO FDA ON (B)(4) /2015. NO ADVERSE EVENT RESULTED FROM THE PULSE RESET. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 01/2014 - INITIAL USE. ELECTRODE BELT SN (B)(4): 11/2012 - REUSE. APPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PTS 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.

    Description of Event or Problem · 1

    A RETROACTIVE REVIEW OF PT FLAG FILES IN THE LIFEVEST NETWORK IDENTIFIED MULTIPLE POTENTIAL MONITOR RESETS FOLLOWING TREATMENTS ON (B)(6) 2014. ON (B)(6) 2014, THE PT WAS WAITING TO RECEIVE AN ICD IN THE HOSPITAL AT THE TIME OF THE POTENTIAL EVENT. A PHYSICIAN ASSISTANT (PA) CALLED INTO ZOLL AND STATED THAT THE PT RECEIVED A LOWER EXTREMITY ISCHEMIA. THE PA FOND THE PT UNCONSCIOUS ON THE FLOOR. THE PT STATED THAT HE DOES NOT REMEMBER ANYTHING AT ALL. THE HOSPITAL STAFF DID NOT REPORT ANY EVENTS DURING THIS PERIOD. A RETROSPECTIVE REVIEW OF THE PT'S FLAG FILES SUGGESTS THE PT RECEIVED 33 TREATMENTS FROM (B)(6) 2014 AT 07:50:14 TO (B)(6) 2014 AT 13:39:03. THE DEVICE PROPERLY DETECTED FOUR EPISODES OF VENTRICULAR ARRHYTHMIA. TWO WERE SELF-TERMINATING AND THE STATUS OF THE OTHER TWO WERE UNK DUE TO MONITOR RESET. FALSE DETECTIONS APPEAR TO BE CAUSED BY MULTIPLE COUNTING OF TALL T-WAVES. AFTER EACH OF THE TREATMENTS, THE MONITOR RESET. THE RESPONSE BUTTONS WERE PRESSED INFREQUENTLY DURING THE EVENT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT. THE PT ENDED USE ON (B)(6) 2014 BECAUSE THE PT RECEIVED AN ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239965 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR NVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other