BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3964468 · Received May 23, 2014

    Report

    Report Number
    3008642652-2014-01571
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL ON MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING WITH SERVICE CODE 204. THE CAUSE OF THE CODE 204 IS A DISRUPTION IN COMMUNICATION BETWEEN THE MONITOR AND ELECTRODE BELT. THE CAUSE OF THE DISRUPTION IN COMMUNICATION IS A DAMAGED Y402 16 MHZ CRYSTAL. THE ROOT CAUSE OF THE DAMAGED CRYSTAL CANNOT BE POSITIVELY IDENTIFIED. IN ADDITION, CORROSION WAS FOUND ON THE JTAG TABLE BOARD, SD CARD HOLDER, J502 AND U201 COMPONENTS. THE ROOT CAUSE OF THE CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY LIQUID INGRESS OF AN UNK CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A PT SERVICE REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PT TO REPORT A SERVICE CODE 204. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307299 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR