BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3112156 · Received May 3, 2013

    Report

    Report Number
    3008642652-2013-01183
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 29, 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 (DAMAGE BELT CONNECTOR) WAS CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR HOUSING WAS BROKEN. THE CONNECTOR LOCKING NUT WAS MISSING, WHICH WOULD PREVENT THE ELECTRODE BELT FROM PROPERLY SECURING INTO THE MONITOR. THE ROOT CAUSE FOR THE MISSING LOCKING NUT CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE FITTING AN (B)(6) MALE PATIENT TO REPORT THAT THE BELT CONNECTOR WAS DAMAGED. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195648 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR