BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843836 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02839
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE MONITOR FAILED A PULSE TEST. UPON SERVICE INVESTIGATION IT WAS DISCOVERED THAT TWO OF THE HIGH VOLTAGE CAPACITORS SOLDER CONNECTIONS WERE BROKEN. THE NEGATIVE AND POSITIVE TERMINALS OF THE HIGH-VOLTAGE CAPACITOR C22 WERE BROKEN FREE FROM THE SOLDER CONNECTION. THE CAUSE OF THE LIFTED PADS ON THE C22 CAPACITOR CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY SEVERE MECHANICAL SHOCK FROM PHYSICAL IMPACT. NO ADVERSE EVENT OCCURRED DUE TO THE DAMAGED MONITOR. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, MONITOR SN (B)(4) DISPLAYED A SERVICE CODE 203 (PULSE TEST FAULT). THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    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 NA