BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3844837 · Received March 12, 2014

    Report

    Report Number
    3008642652-2014-00776
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 11, 2014
    Report Date
    March 10, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE CHARGER WAS RESETTING. THE CAUSE OF THE RESETS WAS ISOLATED TO THE CHARGER/MODEM'S CA BOARD. THE ROOT CAUSE FOR THE RESETS WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY RELATED TO AN INTERMITTENT BGA CONNECTION ON THE CA BOARD. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED SOLDER CONNECTION INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE FRACTURED CONNECTION MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER / MODEM. THE LAST PATIENT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, CHARGER/MODEM SN (B)(4) WAS RESETTING. THE LAST PATIENT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149296 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA