BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3964456 · Received May 23, 2014

    Report

    Report Number
    3008642652-2014-01582
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN: (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 102) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING AND DISPLAYED SERVICE CODE 102. THE CAUSE FOR THE CODE 102 AND INCOMING TEST FAILURE IS AN OPEN RESISTOR R45 ON THE COMPUTER/ANALOG (CA) BOARD. THE CAUSE FOR THE OPEN RESISTOR IS EXCESSIVE CURRENT. THE CAUSE FOR THE EXCESSIVE IS BROKEN LEADS ON HIGH-VOLTAGE CAPACITORS C21 AND C22 ON THE DEFIBRILLATOR BOARD. THE ROOT CAUSE FOR THE BROKEN LEADS ON C21 AND C22 COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR IMPACTING A HARD SURFACE. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE (B)(4) TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON 12/20/2012. IMPLEMENTATION BEGAN ON 01/21/2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONNECTED A (B)(6) YEAR OLD FEMALE PATIENT TO EXCHANGE HIS MONITOR. THE PATIENT'S DOWNLOADED DATA REVEALED MULTIPLE OCCURRENCES OF SERVICE CODE 102. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307297 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR