BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4259339 · Received November 12, 2014

    Report

    Report Number
    3008642652-2014-03939
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 13, 2014
    Report Date
    November 11, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO LATCH WITH A TEST BELT) WAS CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING. UPON EVALUATION, THE BELT RECEPTACLE WAS DAMAGED. THE CAUSE OF THE TEST FAILURE IS THE DAMAGED RECEPTACLE. THE ROOT CAUSE OF THE DAMAGED RECEPTACLE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED RECEPTACLE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED MONITOR SN (B)(4) INDICATING THAT THE MONITOR WAS UNABLE TO SECURELY LATCH A TEST BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728144 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILALTOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA