BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3073100 · Received April 8, 2013

    Report

    Report Number
    3008642652-2013-00921
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 2, 2013
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED THE INCOMING PULSE TEST WITH ASSOCIATED SERVICE CODE 203. THE CAUSE OF THE PULSE TEST FAILURE IS A DAMAGED R84 (CURRENT SENSING RESISTOR) AND BROKEN SOLDER CONNECTIONS AT U901 (QUAD MICRO POWER OP AMMP). THE ROOT CAUSE OF THE DAMAGE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY SEVERE MECHANICAL IMPACT, AS THE MONITOR CASE SHOWED EVIDENCE OF PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED R84 AND U901 COMPONENTS. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, MONITOR SN (B)(4) FAILED THE INCOMING PULSE TEST WITH ASSOCIATED SERVICE CODE 203. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144438 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA