BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061743 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00890
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 29, 2013
    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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. DURING INCOMING TESTING, THE MONITOR DELIVERED ONE 115.1J PULSE AND FOUR NORMAL 150J PULSES. THE CAUSE FOR THE TEST FAILURE IS THE LOW PULSE ENERGY OF THE FIRST PULSE DELIVERY. THE CAUSE OF THE LOW PULSE ENERGY IS AN INTERMITTENT CONNECTION ON MODIFICATION 2 (MOD2). MOD2 IS A MODIFICATION ON THE OUTPUT OF THE MUX (ANALOG SIGNAL MULTIPLEXER) WHICH ELIMINATES NOISE AND ERRONEOUS MEASUREMENTS. THE ROOT CAUSE OF THE INTERMITTENT CONNECTION COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE INTERMITTENT CONNECTION. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT FOR AN UNRELATED ISSUE. DURING SERVICING, A REPORTABLE PROBLEM WAS DISCOVERED. THE MONITOR FAILED THE INCOMING PULSE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130026 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR