BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3812668 · Received April 25, 2014

    Report

    Report Number
    3008642652-2014-01235
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 OR WIRES EXPOSED) WAS CONFIRMED. UPON INVESTIGATION, THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM THE STRAIN RELIEF. THIS RESULTED IN AN INTERMITTENT CONNECTION BETWEEN THE CABLE AND DN. THE ROOT CAUSE OF THE PULLED CABLES COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE MOTHER OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THE PT'S ELECTRODE BELT HAD EXPOSED WIRES. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250913 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR