BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3023373 · Received March 1, 2013

    Report

    Report Number
    3008642652-2013-00555
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 22, 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 OR WIRES EXPOSED) HAS BEEN CONFIRMED. AS RECEIVED, THE DISTRIBUTION NODE (DN) TO REAR TE CABLE WAS PULLED FROM STRAIN RELIEF. THE ROOT CAUSE OF THE PULLED CABLE CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FORM THE DAMAGED ELECTRODE BELT CABLE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90529 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR