BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3073075 · Received April 8, 2013

    Report

    Report Number
    3008642652-2013-00949
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 3, 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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLE) HAS BEEN CONFIRMED. UPON EVAL, THE CABLE CONNECTING THE REAR THERAPY ELECTRODE (TE) AND THE DISTRIBUTION NODE (DN) WAS PULED FROM THE DN STRAIN RELIEF, DAMAGING INTERNAL WIRES. THE ROOT CAUSE OF THE DAMAGED CABLE AND WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. THE PT RECEIVED A REPLACEMENT BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT ONE OF THE CABLES ON THE PT'S BELT WAS DAMAGED. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142821 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR