BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2911217 · Received December 14, 2012

    Report

    Report Number
    3008642652-2012-03287
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 11, 2012
    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 EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON PAST HOME SCREEN) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER/MODEM WOULD NOT POWER ON PAST THE HOME SCREEN. UPON EVAL, COMPONENT U13 (8-BIT CMOS FLASH MICRO-CONTROLLER) WAS CORRUPT AND WOULD NOT PROGRAM. THE CAUSE FOR THE INABILITY TO POWER ON IS THE DEFECTIVE U13 COMPONENT. THE ROOT CAUSE OF THE DEFECTIVE U13 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U13 COMPONENT. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    AN (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER/MODEM WOULD NOT POWER ON PAST THE HOME SCREEN. 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 88 YR