BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221461 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00439
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 15, 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 (EXPOSED WIRES) HAS BEEN CONFIRMED. AS RECEIVED THE CABLE RUNNING FROM THE DISTRIBUTION NODE TO THE REAR TWO WIRE THERAPY ELECTRODE WAS RIPPED FROM THE DISTRIBUTION NODE, EXPOSING WIRES. IN ADDITION, THE CABLE RUNNING FROM THE DISTRIBUTION NODE TO ELECTRODE NODES C AND D WAS RIPPED FROM THE DISTRIBUTION NODE, EXPOSING WIRES. THE CAUSE FOR THE DAMAGED CABLES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRES. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S DAUGHTER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT EXPOSED WIRES NEAR THE TACTILE ALARM. THE PT WAS ISSUED 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 63 YR