BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221450 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00472
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 17, 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 CHARGER/MODEM (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER/MODEM NOT WORKING) HAS BEEN CONFIRMED. UPON EVAL, THE CHARGER/MODEM WAS RESETTING AT THE INSERT BATTERY SCREEN BEFORE THE UNIT COULD COMPLETELY BOOT UP. THE ROOT CAUSE OF THE RESETS WAS CRACKS IN THE BGA SOLDER JOINTS FOR THE U1003 COMPONENT. (B)(4). NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS CHARGER/MODEM WAS NOT WORKING. THE PT 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 66 YR