BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2233008 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00264
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 20, 2011
    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 BEEN COMPLETED. THE REPORTED PROBLEM (CONNECTOR HAS EXPOSED WIRES) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WAS RIPPED FROM THE STRAIN RELIEF, EXPOSING THE TRUNK CABLE CONNECTOR'S WIRES. THE ROOT CAUSE OF THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE TRUNK CABLE CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE DAUGHTER OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BELT CONNECTOR HAD WIRES EXPOSED AND WAS UNABLE TO CONNECT TO THE MONITOR. THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR