BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3941308 · Received April 11, 2014

    Report

    Report Number
    3008642652-2014-01071
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT RECOGNIZE BATTERY PACK) WAS CONFIRMED. AS RECEIVED, THE CHARGER/MODEM WAS RESETTING. UPON EVALUATION, THERE WAS CORRUPTED DATE ON THE FLASH MEMORY. THE CAUSE OF THE INABILITY TO RECOGNIZE A BATTERY PACK IS THE CORRUPTED DATA CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPTED DATA. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER/MODEM WOULD NOT RECOGNIZE A BATTERY PACK. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220454 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR