BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3112118 · Received May 3, 2013

    Report

    Report Number
    3008642652-2013-01156
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 24, 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. AS REC'D THE MONITOR FAILED INCOMING PULSE TESTING WITH ASSOCIATED CODE 203 - PULSE TEST FAULT. THE CAUSE FOR THE CODE 203 IS IN ABILITY TO FIRE A PULSE. THE CAUSE FOR THE INABILITY TO FIRE A PULSE IS LOW RESISTANCE ON THE +10.8DF LINE. THE CAUSE OF THE LOW RESISTANCE IS DEFECTIVE IGT CONTROL MOSFET DRIVERS (U15, U16, U17, U18) ON THE DEFIBRILLATOR BOARD. THE ROOT CAUSE OF THE DEFECTIVE DRIVERS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE DRIVERS. 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 A PULSE TESTING WITH ASSOCIATED CODE 203. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193485 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA