BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843874 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02775
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 9, 2012
    Report Date
    October 18, 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 105 - PULSE TEST RELAY FAULT) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR FAILED A PULSE TEST. UPON RECEIPT THE MONITOR HAD CONFORMAL COATING ON THE INTERBOARD CONNECTIONS, (B)(4). ONCE THE CONNECTIONS WERE CLEANED THE MONITOR PASSED THE PULSE TEST. THE ROOT CAUSE OF THE CONFORMAL COAT ON THE CONNECTIONS WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY AN ERROR IN MANUFACTURING. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) FEMALE PATIENT TO EXCHANGE HER MONITOR. THE PATIENT'S DOWNLOAD REVEALED 'PULSE TEST RELAY CHECK FAULT' FLAGS. THE PATIENT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    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 82 YR