BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3072332 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00910
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON SVC INVESTIGATION THE MONITOR FAILED A BELT START-UP TEST. UPON EVALUATION, THERE WAS A SOLDER BRIDGE ACROSS CAPACITOR C652. THE CAUSE OF THE TEST FAILURES IS THE SOLDER BRIDGE ACROSS THE CAPACITOR. THE ROOT CAUSE OF THE SOLDER BRIDGE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY ASSEMBLY ERROR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A REVIEW OF SVC DATA REVEALED A REPORTABLE EVENT WITH MONITOR SN (B)(4). UPON SVC INVESTIGATION, THE MONITOR FAILED THE BELT START-UP TEST. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142031 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA