BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843844 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02862
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 25, 2012
    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 SUMMARY: DEVICE EVAL OF BATTERY CHARGER/MODEL SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS RESETTING. THE OUTPUT OF PIN 1 OF U13 (CMOS FLASH MICROCONTROLLER) ON THE BEDSIDE PCA BOARD WAS LOW, WHICH CAUSED THE RESETS. AN INTERMITTENT BGA CONNECTION WAS ALSO DISCOVERED ON THE FLASH MEMORY CHIPS (U102 AND U105) ON THE C/A BOARD. THE ROOT CAUSE FOR THE INTERMITTENT FLASH BGA CONNECTIONS AND THE DEFECTIVE U13 MICROCONTROLLER COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    WHILE INVESTIGATING A (B)(6) MALE PT'S BATTERY CHARGER/MODEM FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE BATTERY CHARGER/MODEM WAS RESETTING. THE PT WAS ISSUED A REPLACEMENT BATTERY 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 74 YR