BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4792647 · Received May 20, 2015

    Report

    Report Number
    3008642652-2015-03323
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 19, 2015
    Report Date
    May 15, 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

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION. THERE IS NO INDICATION THAT THE PATIENT SUSTAINED A SERIOUS INJURY. DEVICE EVALUATION OF MONITOR SN (B)(4) WAS ACCOMPLISHED THROUGH A REVIEW OF THE PATIENT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE DEFIBRILLATION EVENT. DEVICE EVALUATION OF BELT SN (B)(4) WAS COMPLETED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THERE WAS CORROSION IN ECG C AND RESISTOR R6 AND DIODE D3 WERE OXIDIZED. THE DAMAGED ECG ONLY AFFECTED THE SIDE-SIDE ECG CHANNEL. THE FRONT-BACK ECG CHANNEL WAS FULLY FUNCTIONAL, THEREFORE THE BELT WAS STILL ABLE TO DETECT AND TREAT A PATIENT. THERE IS NO INDICATION THAT THE DAMAGED ECG CAUSED THE DEFIBRILLATION EVENT. A REVIEW OF THE EVENT INDICATES THAT MOTION ARTIFACT ON THE FRONT-BACK ECG CHANNEL CONTRIBUTED TO THE FALSE DETECTION. INAPPROPRIATE DEFIBRILLATIONS ARE ON 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.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL ON (B)(6) /2015 TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. THE PATIENT WAS REPORTEDLY WAKENED BY THE ALARMS BUT WAS UNABLE TO PRESS THE RESPONSE BUTTONS. THE PATIENT WAS TREATED AT 01:36:18 ON (B)(6) 2015. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. A REVIEW OF THE EVENT INDICATES THAT THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PATIENT CONTINUED USE OF THE LIFEVEST. (B)(4) 07082534 - REUSE. ELECTRODE BELT: (B)(4): 09/01/2014 - REUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327795 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other