BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1843686 · Received September 21, 2010

    Report

    Report Number
    3002158293-2010-00953
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) HAS BEEN CONFIRMED. AS REC'D, THE CHARGER WAS FOUND TO HAVE DEFECTIVE COMPONENTS. THE FLASH MEMORY CHIPS (COMPONENTS U102 AND U105) WERE CORRUPT AND NEEDED TO BE REPLACED. THE ROOT CAUSE OF THE DEFECTIVE FLASH MEMORY CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT MEMORY. THE PT REC'D A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    THE PT SERVICE REP (PSR) ASSISTING A (B)(6) FEMALE PT CALLED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT'S CHARGER WAS NOT WORKING. THE PSR REPORTED TO HAVE PLUGGED THE CHARGER INTO SEVERAL OUTLETS WITHOUT SUCCESS. SUPPORT ISSUED THE PT A REPLACEMENT CHARGER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR