BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232918 · Received July 21, 2011

    Report

    Report Number
    3008642652-2011-00271
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 20, 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. AS RECEIVED, THE TRUNK CABLE CONNECTOR WAS DAMAGED AND THE CABLE RUNNING FROM THE DISTRIBUTION NODE TO ECG B WAS PULLED FROM THE STRAIN RELIEF. THE ROOT CAUSE OF THE DAMAGED BELT CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    DURING THE INVESTIGATION OF ELECTRODE BELT SN (B)(4) FOR AN UNRELATED COMPLAINT, A REPORTABLE PROBLEM WAS DETECTED DURING SERVICING. THE DISTRIBUTION NODE TO ECG B CABLE WAS PULLED FROM THE STRAIN RELIEF, AND THE TRUNK CABLE WAS DAMAGED. THE PATIENT 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 59 YR