BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1011955 · Received March 11, 2008

    Report

    Report Number
    3002158293-2008-00099
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MONITOR. BATTERY PACK - 12/2007. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR AND BATTERY PACK HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE FOR THE MONITOR "NOT POWER UP" WAS A DEFECTIVE CA BOARD THAT HAD INTERMITTENT COMMUNICATION WITH THE HYPER TERMINAL. THE GROUND PLANE WAS NOT CONNECTED AT ALL POINTS. THE ROOT CAUSE OF THE DEFECTIVE CA BOARD IS UNKNOWN, BUT IS LIKELY RANDOM COMPONENT FAILURE. THE MONITOR WAS REPAIRED, RETESTED AND RESTOCKED. THE BATTERY PACK HAD DEFECTIVE CELLS THAT WERE PROBABLY CAUSED BY CURRENT DRAW FROM THE MONITOR. THE BATTERY PACK WAS REPAIRED, RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR OR BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT MONITOR AND BATTERY PACK.

    Description of Event or Problem · 1

    A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE CHANGED HIS BATTERY PACKS AND UPON INSERTING THE FRESHLY CHARGED BATTERY PACK, THE BUTTONS LIT UP RED, BUT NOTHING CAME ON THE SCREEN. HE PRESSED THE BUTTONS, BUT THEY WOULD NOT STOP BEING RED. HE THEN TOOK THE BATTERY PACK OUT AND CALLED SUPPORT. SUPPORT HAD THE PATIENT REINSERT THE BATTERY PACK, AND THE TACTILE ALARM BEGAN VIBRATING AND WOULD NOT STOP, THE SCREEN REMAINED BLANK THE ENTIRE TIME. SUPPORT HAD THE PATIENT PRESS THE RESPONSE BUTTONS AND THE VIBRATION STOPPED. SUPPORT HAD THE PATIENT PRESS THE RESPONSE BUTTONS TO SEE IF THE SOUND OF A MANUAL RECORDING COULD BE HEARD AND NOTHING HAPPENED. SUPPORT THEN HAD THE PATIENT CONNECT THE MODEM TO SEE IF A DOWNLOAD WAS POSSIBLE. NOTHING HAPPENED. THE PATIENT WAS SENT A REPLACEMENT BATTERY PACK AND MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR