BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2510797 · Received March 23, 2012

    Report

    Report Number
    3008642652-2012-00725
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 19, 2012
    Report Date
    March 23, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETE. THE REPORTED PROBLEM (AVERAGE CURRENT CONSUMPTION TOO HIGH) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS DRAWING TOO MUCH CURRENT. IN ADDITION THE MONITOR FAILED A PULSE DELIVERY TEST. THE CAUSE OF THE IMPROPERLY FUNCTIONING MONITOR WAS A DEFECTIVE COMPONENT U28 (24 BIT DIGITAL SIGNAL PROCESSOR BGA). U28 WAS DRAWING TOO MUCH CURRENT FROM THE MONITOR. IN ADDITION, THIS CAUSE COMPONENTS Q10, Q12, Q13, Q16 AND Q17 TO BE OF TOLERANCE. THE ROOT CAUSE OF THE DEFECTIVE U28 WAS UNABLE TO BE POSITIVELY IDENTIFIED, HOWEVER THE FAILURE RATE FOR THIS COMPONENT IS LOW. NO ADVERSE EVENT RESULTED FROM THE IMPROPERLY FUNCTIONING MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A REVIEW OF THE DOWNLOAD DATA OF A (B)(6) OLD MALE PT REVEALED AN AVERAGE CURRENT CONSUMPTION TOO HIGH FLAG. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR