BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3033155 · Received March 1, 2013

    Report

    Report Number
    3008642652-2013-00565
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 (DOES NOT POWER ON PROPERLY) HAS BEEN CONFIRMED. UPON EVALUATION, THE MONITOR WOULD NOT POWER ON. THE CAUSE OF THE INABILITY TO POWER ON IS CORRUPTED FILES ON THE SD CARDS. THE ROOT CAUSE OF THE DEFECTIVE SD CARD CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90283 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR