BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2220618 · Received July 15, 2011

    Report

    Report Number
    3008642652-2011-00230
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 17, 2011
    Report Date
    July 15, 2011
    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 EVAL SUMMARY: DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) HAS BEEN CONFIRMED. THE CAUSE OF THE DEFECTIVE MONITOR WAS DETERMINED TO BE CORRUPTED SOFTWARE. THE CAUSE OF THE CORRUPTED SOFTWARE WAS A DEFECTIVE FLASH MEMORY CHIP ON THE CA BOARD OF THE CHARGER. ONCE THE FLASH MEMORY ON THE CA BOARD (COMPONENTS U102 AND U105) IS REPLACED, THE UNIT WILL OPERATE NORMALLY. THE ROOT CAUSE OF THE DEFECTIVE FLASH MEMORY CHIP 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) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A DEFECTIVE MONITOR. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR