BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2844817 · Received November 2, 2012

    Report

    Report Number
    3008642652-2012-02866
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 25, 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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ELECTRODE BELT NOT FUNCTIONING PROPERLY) HAS BEEN CONFIRMED. UPON EVALUATION, THE PIN CONNECTING THE ECG DOME OF ELECTRODE D WAS BROKEN FORM THE PCB INSIDE THE ELECTRODE. THE CAUSE OF IMPROPERLY FUNCTIONING ELECTRODE BELT WAS THE DETACHED DOME PIN FROM THE PCB. THE ROOT CAUSE OF THE DETACHED DOME PIN WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PT TO REPORT THAT THE PT'S ELECTRODE BELT WAS NOT FUNCTIONING PROPERLY. THE PT WAS GIVEN A REPLACEMENT ELECTRODE BELT.

    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 74 YR