BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3844880 · Received March 12, 2014

    Report

    Report Number
    3008642652-2014-00793
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 10, 2014
    Report Date
    March 11, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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 (DAMAGED CABLE) WAS CONFIRMED. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE TO ECG "C" WAS SEVERED. THE ROOT CAUSE FOR THE CUT CABLE WAS PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE CUT CABLE. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER ELECTRODE BELT CABLE WAS DAMAGED. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149255 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR