BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961395 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00186
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 16, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 102) WAS CONFIRMED. THE CAUSE FOR THE CODE 102 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 CURRENT IS A BROKEN NEGATIVE LEA ON HIGH-VOLTAGE CAPACITOR C21 ON THE DEFIBRILLATOR BOARD. THE EXCESSIVE CURRENT ALSO SHORTED COMPONENTS U15-U18 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. (B)(4). NO ADVERSE EVENT RESULTED FROM THE BROKEN LEAD ON C21. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PATIENT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A CODE 102 - CHARGE PROFILE FAULT. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27751 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR