BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2190034 · Received June 29, 2011

    Report

    Report Number
    3008642652-2011-00111
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 28, 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. THE REPORTED PROBLEM (DAMAGED CABLE OR WIRES EXPOSED) HAS BEEN CONFIRMED. UPON EVAL, THE TRUNK CABLE AND CONNECTOR WERE DAMAGED. THE DAMAGE TO THE TRUNK CABLE OCCURRED BETWEEN THE DISTRIBUTION NODE AND THE FRONT THERAPY ELECTRODE. THE CAUSE FOR THE DAMAGED CABLE AND CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR AND CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE DAMAGED HIS ELECTRODE BELT AND IT WOULD NO LONGER WORK. 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 17 YR