BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2231381 · Received July 26, 2011

    Report

    Report Number
    3008642652-2011-00289
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 18, 2011
    Report Date
    July 25, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED BELT CONNECTOR) HAS BEEN CONFIRMED. UPON EVALUATION, THE ELECTRODE BELT TRUNK CABLE CONNECTOR WAS DAMAGED. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT CABLE CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT. DEVICE EVALUATION OF CHARGER/MODEL SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER SCREEN BLACK) HAS BEEN CONFIRMED. UPON RECEIPT, THE CHARGER/MODEM SCREEN WAS BLACK AND WOULD NOT POWER UP. THE CAUSE FOR THE INABILITY TO POWER UP IS DUE TO A DEFECTIVE POWER SUPPLY. THE ROOT CAUSE FOR THE DEFECTIVE POWER SUPPLY CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM. DEVICE MANUFACTURE DATE: ELECTRODE BELT SN (B)(4); CHARGER/MODEM SN (B)(4): 05/2010.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A DAMAGED BELT CONNECTOR. WHEN A PATIENT SERVICE REPRESENTATIVE (PSR) VISITED THE PATIENT TO EXCHANGE THE ELECTRODE BELT, PSR REPORTED A BLACK SCREEN ON THE CHARGER/MODEM. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT AND CHARGER/MODEM.

    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 62 YR