BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2243655 · Received July 27, 2011

    Report

    Report Number
    3008642652-2011-00292
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 19, 2011
    Report Date
    July 25, 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

    DURING EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP PAST SPLASH SCREEN) WAS CONFIRMED. UPON EVALUATION, THE MONITOR WAS FOUND TO HAVE DEFECTIVE RAM CHIPS (U100 AND U101) AND FLASH MEMORY CHIPS (U102 AND U105). (B)(4). THE FAILURE APPEARS TO BE INTERMITTENT. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED SOLDER CONNECTION INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT MEMORY. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE MONITOR IS NOT POWERING UP PROPERLY. THE MONITOR SCREEN IS BLANK WHEN EITHER BATTERY PACK IS INSERTED. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    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 46 YR