BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881106 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03026
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    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, ADJUST BELT OR CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON RECEIPT, THE ELECTRODE BELT FAILED THE TE RECOGNITION TEST. THE CAUSE WAS AN OPEN PULSE WIRE IN THE DISTRIBUTION NODE (DN) TO FRONT TE CABLE. THE CAUSE FOR THE CHECK THERAPY PAD MESSAGES AND ADJUST BELT OR CHECK BELT MESSAGES WAS THE BROKEN PULSE WIRE. 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 RECEIVED 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 AND ADJUST BELT OR CHECK BELT 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 65 YR