BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961355 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00157
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 14, 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 (GEL PREVIOUSLY RELEASED / INDICATES PHYSICAL DAMAGE) 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 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 ELECTRODE BELT.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) MALE PT TO EXCHANGE HIS ELECTRODE BELT. REVIEW OF THE PT'S FLAGS REVEALED 'GEL PREVIOUSLY RELEASED' FLAGS WITHOUT PRIOR 'GEL RELEASE' FLAGS, INDICATING POTENTIAL PHYSICAL DAMAGE TO THE BELT. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27607 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR