BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2920637 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03238
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 24, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ZOLL LIFECORE CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK ELECTRODE BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED THE HIPOT AND FALLOFF TESTS. THE TRUNK CABLE CONNECTOR WAS CRACKED, AND THE DRIVEN GROUND WIRE IN THE CONNECTOR WAS OPEN. IN ADDITION, THE PULSE WIRE WAS OPEN BETWEEN ECG "A" AND ECG "B". THE OPEN WIRES CAUSED THE REPORTED CHECK ELECTRODE BELT MESSAGES. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR AND OPEN WIRES COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTS FROM THE DAMAGED CONNECTOR AND BROKEN WIRES. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT WAS RECEIVING CHECK ELECTRODE 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 LIFECORE CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR