BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3072304 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00943
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 3, 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 EVAL SUMMARY - DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED THE MONITOR FAILED INCOMING PULSE TEST DUE TO AN INABILITY TO DELIVER A PULSE. THE CAUSE FOR THE INABILITY TO DELIVER A PULSE IS THE INABILITY OF THE CONVERTER TO CHARGE. THE CAUSE FOR THE INABILITY TO CHARGE THE CONVERTER IS A DAMAGED RESISTOR R30 (SM POWER RESISTOR) ON THE COMPUTER / ANALOG (CA) BOARD. ONE OF THE RESISTOR LEADS WAS DETACHED FROM THE CA BOARD. THE ROOT CAUSE OF THE DETACHED LEAD CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY MECHANICAL SHOCK FROM PHYSICAL IMPACT. NO ADVERSE EVENT RESULTED FROM THE BROKEN LEAD ON R30. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, MONITOR SN (B)(4) FAILED THE INCOMING 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
    140152 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA