BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221481 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01754
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CANNOT BASELINE PATIENT) WAS CONFIRMED. UPON INVESTIGATION, IT WAS DISCOVERED THAT RESISTOR R781 ON THE MONITOR CA BOARD WAS OPEN, CAUSING A FAILURE OF THE MONITOR'S DRIVEN GROUND CIRCUITRY. THE DRIVEN GROUND FAILURE PREVENTED THE MONITOR FROM PERFORMING A BASELINE. THE ROOT CAUSE FOR THE OPEN RESISTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS UNABLE TO BASELINE A (B)(6) MALE PATIENT. THE PATIENT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301493 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR