BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2024030 · Received March 14, 2011

    Report

    Report Number
    3002158293-2011-00295
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 10, 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 (CODE 204, BELT WON'T STAY LATCHED TO MONITOR) HAS BEEN CONFIRMED. UPON EVALUATION THE TRUNK CABLE CONNECTOR WAS BROKEN. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS SYSTEM DISPLAYED A SERVICE CODE 204. HE ALSO STATED THAT HIS CONNECTOR DOES NOT SIT SECURELY IN THE MONITOR. 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 55 YR