BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2841345 · Received October 23, 2012

    Report

    Report Number
    3008642652-2012-02841
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 27, 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 AND DISPLAYED SERVICE CODE 102. UPON INVESTIGATION, THE HIGH-VOLTAGE CAPACITOR C19 WAS FOUND TO HAVE A FRACTURED SOLDER CONNECTION ON THE DEFIBRILLATOR BOARD, PREVENTING THE CAPACITORS FROM CHARGING. THE CAUSE OF THE FAILED PULSE TEST AND CHARGE PROFILE FAULT IS THE FRACTURED SOLDER CONNECTION OF C19. THE CAUSE OF THE FRACTURED CONNECTION IS LIKELY SEVERE MECHANICAL SHOCK FROM PHYSICAL IMPACT. THE SOURCE OF THE PHYSICAL IMPACT CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, MONITOR SN (B)(4) FAILED THE PULSE TEST WITH ASSOCIATED SERVICE CODE 203 AND DISPLAYED SERVICE CODE 102 - CHARGE PROFILE FAULT. THE LAST PATIENT 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