BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3002556 · Received February 15, 2013

    Report

    Report Number
    3008642652-2013-00402
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 11, 2013
    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 (CHECK ELECTRODE BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE WAS CUT AND PULLED FROM THE DISTRIBUTION NODE, WHICH DAMAGED COMPONENT T9 AND CAUSED THE REPORTED CHECK ELECTRODE BELT ALARMS. THE ROOT CAUSE FOR THE DAMAGE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT SHE WAS RECEIVING FREQUENT CHECK ELECTRODE BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67583 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR