BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2821962 · Received September 28, 2012

    Report

    Report Number
    3008642652-2012-02523
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 9, 2012
    Report Date
    September 24, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED THE PULSE TEST UPON EVAL, THE SOLDER PADS OF HIGH-VOLTAGE CAPACITORS C19, C20, AND C21 WERE DETACHED FROM THE PCB. THE CAUSE OF PULSE TEST FAILURE IS THE DETECTED HIGH-VOLTAGE CAPACITOR SOLDER PADS. THE CAUSE OF THE DETACHED SOLDER PADS IS LIKELY MECHANICAL SHOCK FROM PHYSICAL IMPACT, AS THERE WERE SIGNS OF PHYSICAL DAMAGE TO THE MONITOR CASE. THE SOURCE OF THE PHYSICAL IMPACT CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SVC DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, MONITOR SN (B)(4) FAILED THE PULSE TEST. 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