BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3821207 · Received April 29, 2014

    Report

    Report Number
    3008642652-2014-01320
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    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 SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 102) WAS CONFIRMED. UPON RECEIPT, THE MONITOR FAILED INCOMING FUNCTIONAL TESTING. THE CAUSE FOR THE TEST FAILURE WAS ISOLATED TO AN OPEN R45 RESISTOR ON THE MONITOR C/A BOARD. THE OPEN R45 PREVENTED THE HIGH VOLTAGE BOARD FROM CHARGING TO THE PROPER ENERGY AND THUS CAUSING THE CODE 102. THE ROOT CAUSE FOR THE OPEN R45 RESISTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN RESISTOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    UPON REVIEW OF A (B)(6) MALE PT'S FLAG FILES ZOLL CUSTOMER SUPPORT REPORTED A CODE 102. THE PT WAS CONTACTED AND ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256872 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR