BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080851 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-01019
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 9, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEL SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER RESETTING) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO RECOGNIZE A BATTERY. THE CAUSE FOR THE CHARGER FAILURE WAS ISOLATED TO A SHORTED U13 (CMOS MICRO-CONTROLLER) AND SHORED Q1 (CURRENT CONTROLLING TRANSISTOR) ON THE BEDSIDE BOARD. THE ROOT CAUSE FOR THE SHORTED COMPONENTS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED COMPONENTS. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER/MODEM WAS RESETTING. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158446 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR