BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2241533 · Received August 9, 2011

    Report

    Report Number
    3008642652-2011-00396
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    June 6, 2011
    Report Date
    August 8, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE TRUNK CABLE CONNECTOR WAS CRACKED. THE CAUSE OF THE CRACKED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO A RESULT OF EXCESSIVE FORCE. ONCE THE TRUNK CABLE WAS REPLACED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    DURING THE INVESTIGATION OF ELECTRODE BELT (B)(4) FOR AN UNRELATED COMPLAINT, A REPORTABLE PROBLEM WAS DETECTED DURING SERVICING. THE TRUNK CABLE CONNECTOR WAS CRACKED. THE PT WAS PROVIDED WITH 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 61 YR