BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3812947 · Received April 25, 2014

    Report

    Report Number
    3008642652-2014-01284
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK BELT MESSAGES, UNABLE TO BASELINE) HAS BEEN CONFIRMED. UPON EVALUATION, THE PIN CONNECTING THE ECG DOME OF ELECTRODE B TO THE PCB WAS BROKEN FROM THE DOME INSIDE THE ELECTRODE. THE CAUSE OF THE INABILITY TO BASELINE AND CHECK BELT MESSAGES WAS THE DETACHED DOME PIN. THE ROOT CAUSE OF THE DETACHED DOME PIN WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL PT SERVICE REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) FEMALE PT TO REPORT THAT THE PT'S DEVICE WAS ALARMING WITH ADJUST BELT OR CHECK BELT MESSAGES AND WAS UNABLE TO BASELINE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251187 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR