BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3072339 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00891
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 7, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER/MODEM WAS EXPERIENCING RESETS AND WOULD NOT CHARGE A BATTERY PACK. UPON EVALUATION, COMPONENT U13 (8-BOT CMOS FLASH MICRO-CONTROLLER) WAS SHORTED ON THE BEDSIDE BOARD. THE CAUSE OF THE INABILITY TO CHARGE AND THE RESETS IS THE SHORTED U13 COMPONENT. THE ROOT CAUSE OF THE SHORTED U13 COMPONENT CANNOT NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED U13 COMPONENT. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT THAT THE BATTERY CHARGER/MODEM WAS RESETTING AND WOULD NOT CHARGE HIS BATTERY PACKS. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140282 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR