BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3223933 · Received July 5, 2013

    Report

    Report Number
    3008642652-2013-01793
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLES) HAS BEEN CONFIRMED. UPON INVESTIGATION CABLE CONNECTING THE DISTRIBUTION NODE TO THE REAR THERAPY ELECTRODES WAS SEVERED. THE ROOT CAUSE FOR THE SEVERED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE SEVERED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A NURSE CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PT'S ELECTRODE BELT HAD DAMAGED CABLES. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308245 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR