BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173242 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01506
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 10, 2013
    Report Date
    June 3, 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 SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS NOT BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE MODE 204) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS A CRACKED TRUNK CABLE CONNECTOR. THE RED (CAN H) WIRE WAS OPEN INSIDE OF THE CONNECTOR. THE ROOT CAUSE FOR THE CRACKED CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE IN THE CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS RECEIVING A SERVICE CODE 204. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253997 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR