BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2904567 · Received December 3, 2012

    Report

    Report Number
    3008642652-2012-03122
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE CONNECTOR LOCKING NUT WAS BROKEN, WHICH WOULD PREVENT THE ELECTRODE BELT FROM PROPERLY SECURING INTO THE MONITOR. THE ROOT CAUSE FOR THE BROKEN LOCKING NUT CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. DURING SERVICING OF ELECTRODE BELT SN (B)(4), WHICH WAS RETURNED FOR NORMAL MAINTENANCE, THE BELT WAS FOUND TO HAVE A DAMAGED TRUNK CABLE CONNECTOR. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA