BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3003731 · Received February 12, 2013

    Report

    Report Number
    3008642652-2013-00378
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    November 25, 2012
    Report Date
    February 7, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 102) WAS CONFIRMED. UPON INVESTIGATION RESISTOR R45 WAS OPEN ON THE C/A BOARD, WHICH CAUSED THE SVC CODE 102. THE CAUSE FOR THE OPEN R45 RESISTOR WAS A BROKEN LEAD ON HIGH-VOLTAGE CAPACITOR C21 ON THE DEFIBRILLATOR 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. A MECHANICAL DESIGN CHANGE TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON 12/20/2012. NO ADVERSE EVENT RESULTED FROM THE BROKEN LEAD ON C21. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    DOWNLOAD DATA FROM (B)(6) MALE PT REVEALED A SVC CODE 102 (CHARGE PROFILE FAULT). ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND ISSUED HIM A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62199 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR