BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2885306 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03081
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    November 20, 2012
    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 (CHECK THERAPY PAD MESSAGES) HAS BEEN COMPLETED. THE CAUSE OF THE CHECK THERAPY PAD MESSAGES WAS A BROKEN PULSE WIRE INSIDE OF THE DISTRIBUTION NODE (DN) TO FRONT TE CABLE. THE ROOT CAUSE FOR THE BROKEN PULSE WIRE CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY EXCESSIVE FORCE ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE BROKEN PULSE WIRE. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT CHECK THERAPY PAD MESSAGES. 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 31 YR