BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843827 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02798
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 CABLE) WAS CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE WS RIPPED FROM THE STRAIN RELIEF, WHICH BROKE THE J702 CONNECTOR ON THE ELECTRODE BELT DISTRIBUTION NODE PCA BOARD. THE ROOT CAUSE FOR THE DAMAGED CABLE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM DAMAGED TRUNK CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(4) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A PT'S ELECTRODE BELT CABLE WAS DAMAGED. THE PT RECEIVED 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 NA