BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1972673 · Received January 20, 2011

    Report

    Report Number
    3002158293-2011-00069
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 12, 2010
    Report Date
    January 18, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST/CHECK BELT ALARMS) HAS BEEN CONFIRMED. UPON RECEIPT, THE BELT CABLE WAS CUT BETWEEN THE DISTRIBUTION NODE (DN) AND THE REAR THERAPY ELECTRODES AND BETWEEN THE DN AND ECG A. THE CAUSE FOR THE DAMAGED CABLE CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT ON BEHALF OF A (B)(6) YEAR OLD MALE PT TO SUPPORT THAT THE PT IS RECEIVING CONSTANT CHECK/ADJUST BELT MESSAGES. THE PT 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 36 YR