BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173273 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01528
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 6, 2013
    Report Date
    June 6, 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 (MONITOR RESETTING) WAS CONFIRMED. UPON INVESTIGATION OF DEVICE FLAG FILES, THE MONITOR WAS INTERMITTENTLY RESETTING. THE CAUSE FOR THE RESETS WAS ISOLATED TO A DEFECTIVE U104 PXA COMPONENT ON THE MONITOR C/A BOARD. THE ROOT CAUSE FOR THE INTERMITTENT U104 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U104 PXA COMPONENT. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WAS RESETTING. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254004 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR