BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2063033 · Received March 16, 2011

    Report

    Report Number
    3002158293-2011-00323
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 2, 2011
    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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ARRHYTHMIA ALARMS) HAS BEEN CONFIRMED. THE CAUSE FOR THE ARRHYTHMIA ALARMS WAS THE RESULT OF NOISE ON BOTH CHANNELS. UPON RECEIPT, THE ELECTRODE BELT CABLE WAS DAMAGED IN SEVERAL AREAS. THE CABLE WAS CUT, EXPOSING WIRES, BETWEEN ECG A AND ECG B AND BETWEEN ECG B AND THE DISTRIBUTION NODE. THE CABLE DAMAGE BETWEEN ECG B AND THE DISTRIBUTION NODE CAUSED BOTH CHANNELS TO BECOME DISTORTED. THE ROOT CAUSE FOR THE DAMAGE TO THE ELECTRODE BELT CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR