BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3112135 · Received May 3, 2013

    Report

    Report Number
    3008642652-2013-01202
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 1, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR FAILED A PULSE TEST. THE CAUSE WAS THE LEADS ON THE C21 HIGH VOLTAGE CAPACITOR WERE LIFTED FROM THE SOLDER PADS ON THE DEFIBRILLATION BOARD. THE ROOT CAUSE FOR THE BROKEN LEADS COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FRO THE MONITOR IMPACTING HARD SURFACE. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE (SEE PMA SUPPLEMENT S039) TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON 12/20/2012. IMPLEMENTATION BEGAN ON 01/21/2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE BROKEN LEADS. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SVC DATA HAS DETECTED A REPORTABLE EVENT. UPON SERVICING OF MONITOR SN (B)(4), THE MONITOR FAILED THE PULSE TEST. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195716 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA