BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2961458 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00197
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 17, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BENT PINS OR DAMAGED ELECTRODE BELT CONNECTOR) WAS CONFIRMED. AS REC'D, 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 PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS ELECTRODE BELT CONNECTOR WAS DAMAGED. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28312 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR