BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2800072 · Received October 12, 2012

    Report

    Report Number
    3008642652-2012-02670
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    August 23, 2012
    Report Date
    October 5, 2012
    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 EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 102 - CHARGE PROFILE FAULT/DISCHARGE PROFILE FAULT) HAS BEEN CONFIRMED. THE CAUSE OF THE CODE 102 - CHARGE PROFILE FAULTS AND DISCHARGE PROFILE FAULTS IS AN OPEN RESISTOR R-45 ON THE DEFIBRILLATOR BOARD. R45 CONTROLS THE RATE OF CHARGE OF THE HIGH-VOLTAGE CAPACITORS. THE CAUSE OF THE OPEN RESISTOR IS EXCESSIVE CURRENT. THE CAUSE OF THE EXCESSIVE CURRENT IS OPEN CONNECTIONS AT HIGH-VOLTAGE CAPACITOR C20. THE CAUSE OF THE OPEN CONNECTIONS IS DETACHED SOLDER CONNECTIONS ON BOTH LEADS OF C20. THE CAUSE OF THE FRACTURED CONNECTION IS LIKELY MECHANICAL SHOCK FROM PHYSICAL IMPACT. THE SOURCE OF THE PHYSICAL IMPACT CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6), MALE, PATIENT, TO EXCHANGE HIS MONITOR. THE PATIENT'S DOWNLOAD REVEALED MULTIPLE OCCURRENCES OF SERVICE CODE 102 - CHARGE PROFILE FAULT AND 'DISCHARGE PROFILE FAULT' FLAGS. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR