BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2920634 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03197
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 3, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONSTANT CHECK BELT AND CHECK TE PAD ALARMS) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS AN OPEN PULSE WIRE INSIDE THE CABLE CONNECTING ECG ELECTRODES A AND B. THE CAUSE OF THE CHECK BELT AND CHECK TE PAD ALARMS IS THE DAMAGED PULSE WIRE. THE ROOT CAUSE OF THE DAMAGED WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT CHECK BELT AND CHECK TE PAD ALARMS. 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