BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2920503 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03189
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ZOLL 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 (SYSTEM SPEAKER HUMS WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS CONSTANTLY RESETTING. THE CAUSE FOR THE RESETS WAS ISOLATED TO COMMUNICATION FAULTS WITH THE DIGITAL SIGNAL PROCESSOR (DSP) U500 ON C/A BOARD SN (B)(4). THE ROOT CAUSE FOR THE DEFECTIVE U500 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U500 COMPONENT. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A TERRITORY MANAGER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT'S MONITOR WAS MAKING A HIGH PITCHED NOISE. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR