BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2082180 · Received April 29, 2011

    Report

    Report Number
    3002158293-2011-00477
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 15, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST/CHECK/REPLACE BELT MESSAGES) HAVE BEEN CONFIRMED. UPON EVALUATION, THE ELECTRODE BELT CABLE WAS DAMAGED BETWEEN THE DISTRIBUTION NODE AND ECG C. THE CAUSE FOR THE DAMAGED CABLE CANNOT BE POSITIVELY DETERMINED. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADD GEL; CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, THE CASE WAS SEPARATED AT THE SEAM AND THE WHITE CABLE WAS UNPLUGGED FROM (B)(4) ON THE AUXILIARY BOARD. THE UNPLUGGED CABLE CAUSED ADD GEL MESSAGES, TIME AND DATE RESET AND COMMUNICATION PROBLEMS. THE CAUSE FOR THE DAMAGED CASE AND UNPLUGGED CABLE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND SEPARATED CASE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT AND MONITOR. DEVICE MANUFACTURE DATE: ELECTRODE BELT SN (B)(4). MONITOR SN (B)(4): 12/2008.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT IS RECEIVING CHECK BELT MESSAGES AND ADD GEL MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR AND ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR