BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080797 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00982
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 5, 2013
    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 CHARGER/ MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER NOT POWERING ON) HAS NOT BEEN CONFIRMED. UPON EVALUATION, THE POWER BRICK WAS DEFECTIVE. THE CAUSE OF THE DEFECTIVE POWER BRICK IS A DAMAGED CONNECTOR. THE CONNECTOR PINS WERE RECESSED INTO THE CONNECTOR. THE ROOT CAUSE OF THE RECESSED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED POWER BRICK CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER WOULD NOT POWER ON. THE PATIENT RECEIVED A REPLACEMENT CHARGER/ MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158298 LIFEVEST WCD 4000 SYSTEM WEARABLE MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR