BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3190982 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01649
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK THERAPY ELECTRODE ALARMS) WAS CONFIRMED. UPON INVESTIGATION THE BLACK PULSE WIRE WAS OPEN INSIDE OF THE TRUNK CABLE. THE OPEN PULSE WIRE CAUSED THE REPORTED ALARMS. THE ROOT CAUSE FOR THE OPEN PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE ON THE TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL PT SERVICE REP CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT WAS RECEIVING CONSTANT CHECK THERAPY ELECTRODE ALARMS. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282325 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR