BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3072306 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00957
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    October 21, 2012
    Report Date
    April 3, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY - DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 102 - CHARGE PROFILE FAULT) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR FAILED INCOMING TESTING. THE CAUSE FOR THE TEST FAILURES WAS ISOLATED TO BROKEN LEADS ON HIGH-VOLTAGE CAPACITOR C21 ON THE DEFIBRILLATOR BOARD, WHICH CAUSED ARCING THAT LED TO A OPEN RESISTOR, R45, ON THE C/A BOARD. THE ROOT CAUSE FOR THE BROKEN LEAD ON C21 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. (B)(4). NO ADVERSE EVENT RESULTED FROM THE BROKEN LEAD ON C21. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT REPORTED THAT A DATA DOWNLOAD FROM A (B)(6) MALE PT CONTAINED AN OCCURRENCE OF SERVICE CODE 102 - CHARGE PROFILE FAULT. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PT ALL OF WHICH WERE UNSUCCESSFUL. THEREFORE, THE PT WAS NOT ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141862 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR