BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2082143 · Received April 28, 2011

    Report

    Report Number
    3002158293-2011-00468
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 26, 2011
    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/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DARK SCREEN/WILL NOT RESPOND) WAS CONFIRMED. THE CAUSE FOR THE CHARGER/MODEM NOT POWERING UP WAS A DEFECTIVE POWER BRICK. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER BRICK. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER WAS NOT WORKING PROPERLY. HE REPORTED THAT THE SCREEN WAS DARK AND WOULD NOT RESPOND WHEN HE TOUCHED IT. THE PATIENT 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 44 YR