BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2860457 · Received November 5, 2012

    Report

    Report Number
    3008642652-2012-02899
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 30, 2012
    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. THE REPORTED PROBLEM (CHECK BELT ALARMS / DAMAGED WIRES / CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WAS CRACKED AND THE GREEN (+3.3V) WIRE WAS OPEN. THE CAUSE OF THE CHECK BELT ALARMS AND CODE 204 IS THE DAMAGED WIRE. THE CAUSE OF THE DAMAGED WIRE IS THE CRACKED TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE CRACKED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT CHECK BELT ALARMS. THE PATIENT REPORTED THAT THERE WAS ALSO DAMAGED WIRES AT THE BELT CONNECTION AND A SERVICE CODE 204. THE PATIENT 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 68 YR