BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3073067 · Received April 8, 2013

    Report

    Report Number
    3008642652-2013-00900
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 29, 2013
    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 OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT RECOGNIZE BATTERY) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER/MODEM RESET. THE CAUSE FOR THE RESET AND INABILITY TO RECOGNIZE A BATTERY PACK WAS A SHORTED U13 (8-BIT CMOS CLASH MICRO-CONTROLLER) COMPONENT. THE ROOT CAUSE OF THE SHORTED U13 COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S FRIEND CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER/MODEM WOULD NOT RECOGNIZE A BATTERY PACK. THE PT WAS PROVIDED WITH A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144430 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR