BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983515 · Received June 26, 2014

    Report

    Report Number
    3008642652-2014-01977
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 (WON'T POWER UP) WAS CONFIRMED. AS RECEIVED, THE MONITOR WAS RESETTING AT START-UP. UPON INVESTIGATION, CRYSTAL OSCILLATOR Y500 WAS FOUND TO DEFECTIVE ON THE COMPUTER ANALOG BOARD. THE CAUSE OF THE RESETS WAS THE DEFECTIVE Y500. THE ROOT CAUSE OF THE DEFECTIVE Y500 WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER ON COMPLETED. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373961 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR