BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2941684 · Received December 21, 2012

    Report

    Report Number
    3008642652-2012-03318
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 14, 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 ELECTRODE BELT, CHECK THERAPY ELECTRODE MESSAGES) WAS CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE CONNECTOR WAS CRACKED AND THE WHITE (DRIVEN GROUND) WIRE WAS OPEN INSIDE OF THE CONNECTOR. THE OPEN WIRE CAUSED THE REPORTED ELECTRODE BELT ALARMS. THE ROOT CAUSE FOR THE BROKEN CONNECTOR AND OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE BROKEN TRUNK CABLE CONNECTOR AND OPEN DRIVEN GROUND WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS RECEIVING CHECK ELECTRODE BELT AND CHECK THERAPY ELECTRODE 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