BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061779 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00821
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 25, 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 ELECTRODE BELT SN (B)(4)HAS BEEN COMPLETED. THE REPORTED PROBLEM (GEL PREVIOUSLY RELEASED FLAGS, DAMAGED CABLES) HAS BEEN CONFIRMED. UPON EVAL, THE CABLE CONNECTING THE REAR THERAPY ELECTRODE (TE) AND THE DISTRIBUTION NODE (DN) WAS PULLED FROM THE DN STRAIN RELIEF, DAMAGING INTERNAL WIRES. THE CAUSE OF THE GEL PREVIOUSLY RELEASED FLAGS WAS THE DAMAGED CABLE. THE ROOT CAUSE FOR 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 ELECTRODE BELT.

    Description of Event or Problem · 1

    THE DOWNLOAD DATA FOR A (B)(6) MALE PT REVEALED A "GEL PREVIOUSLY RELEASED" FLAG. ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND ISSUED HIM A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129727 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR