BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2844846 · Received November 2, 2012

    Report

    Report Number
    3008642652-2012-02906
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 30, 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 (CHECK THERAPY ELECTRODE MESSAGES, DAMAGED CABLE) WAS CONFIRMED. UPON INVESTIGATION, THE ECG "C" AND "D" CABLE WAS PULLED FROM THE STRAIN RELIEF. EXCESS WIRE BRAIDING WAS FOUND IN ECG "C", WHICH CAUSED ECG "C" TO SHORT. THE ROOT CAUSE OF THE STRAINED ECG CABLE WAS EXCESSIVE FORCE. THE ROOT CAUSE FOR THE EXCESS WIRE BRAIDING WAS AN ASSEMBLY ERROR. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND EXCESS WIRE BRAIDING. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING CHECK THERAPY ELECTRODE MESSAGES AND THAT ONE OF THE CABLES ON HIS ELECTRODE BELT WAS DAMAGED. THE PATIENT WAS ISSUED 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 46 YR