BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2953994 · Received January 15, 2013

    Report

    Report Number
    3008642652-2013-00124
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 10, 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONSTANT ALARMS) HAS BEEN CONFIRMED. UPON EVALUATION, THE R781 RESISTOR WAS OPEN. THE CAUSE OF THE CONSTANT ALARMS IS THE INABILITY TO RECOGNIZE THE THERAPY ELECTRODES. THE CAUSE OF THE INABILITY TO RECOGNIZE THE THERAPY ELECTRODES IS LACK OF DRIVEN GROUND SIGNAL. THE CAUSE OF THE LACK OF DRIVEN GROUND SIGNAL IS THE OPEN R781. THE ROOT CASE OF THE OPEN R781 CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT ALARMS. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22198 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR