BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3842531 · Received February 21, 2014

    Report

    Report Number
    3008642652-2014-00497
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 26, 2014
    Report Date
    February 11, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 (CODE 107) WAS CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WOULD NOT SECURELY CONNECT WITH THE MONITOR. THE CAUSE FOR THE CODE 107 IS THE INSECURE CONNECTION BETWEEN THE ELECTRODE BELT AND THE MONITOR. THE CAUSE FOR THE INABILITY TO SECURELY CONNECT WITH THE MONITOR IS A DEFECTIVE TRUNK CABLE CONNECTOR. THE ROOT CAUSE HAS NOT BEEN POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTRACTED A (B)(6) FEMALE PT TO EXCHANGE HER ELECTRODE BELT. THE PT'S DOWNLOAD REVEALED MULTIPLE OCCURRENCES OF SERVICE CODE 107 - MULTIPLE ABNORMAL SHUTDOWNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109743 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR