BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2033462 · Received March 23, 2011

    Report

    Report Number
    3002158293-2011-00343
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 21, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (TACTILE VIBRATION ALARMS) HAS BEEN CONFIRMED. UPON EVALUATION, PINS WITHIN THE TRUNK CABLE CONNECTOR WERE BENT. THE CAUSE FOR THE TACTILE VIBRATION ALARM WAS THE TACTILE MOTOR RUNNING CONSTANTLY. THE CAUSE FOR THE TACTILE MOTOR RUNNING CONSTANTLY WAS A SHORT WITHIN THE CONNECTOR CAUSED BY BENT CONNECTOR PINS. THE ROOT CAUSE FOR THE BENT PINS CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S DEVICE WAS CONSTANTLY BUZZING ON THE PATIENT'S BACK. THE MONITOR WOULD NOT RESPOND AFTER THE PATIENT PRESSED THE RESPONSE BUTTONS. THE PATIENT WAS PROVIDED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR