BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961256 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00200
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE CHARGER/MODEM WOULD NOT POWER ON. THE CAUSE OF THE INABILITY TO POWER ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD. AN INTERMITTENT CONNECTION WAS DISCOVERED AT PIN A23 OF THE FLASH MEMORY. 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 BUT THE FRACTURED CONNECTION MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. IN ADDITION, THERE WAS CONTAMINATION ON THE BATTERY BOARD. THE CAUSE OF THE CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MEMORY OR CONTAMINATED BATTERY BOARD. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(4) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT FOR AN UNRELATED ISSUE. DURING SERVICING A REPORTABLE PROBLEM WAS DISCOVERED. THE CHARGER/MODEM WOULD NOT POWER ON AND WAS ALSO CONTAMINATED. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28241 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR