BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3003621 · Received February 11, 2013

    Report

    Report Number
    3008642652-2013-00364
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 22, 2012
    Report Date
    February 6, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (GONG ALARMS) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS AN OPEN PULSE WIRE BETWEEN THE DISTRIBUTION NODE (DN) AND ECG ELECTRODE A. THE CAUSE OF THE GONG ALARMS IS THE OPEN PULSE WIRE. THE ROOT CAUSE OF THE OPEN PULSE WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)() MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT GONG ALARMS. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59249 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR