BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2220625 · Received July 15, 2011

    Report

    Report Number
    3008642652-2011-00226
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    September 4, 2010
    Report Date
    July 14, 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 EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEFECTIVE CHARGER) HAS BEEN CONFIRMED. AS RECEIVED, THE POWER SUPPLY CONNECTOR WAS DAMAGED. THE CAUSE OF THE DAMAGE IS DUE TO RECESSED PINS IN THE POWER SUPPLY CONNECTOR. THE ROOT CAUSE OF THE RECESSED PINS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY CONNECTOR. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A PT SERVICE REP CONTACTED CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) FEMALE PT TO REPORT A DEFECTIVE CHARGER. THE PT WAS PROVIDED WITH A REPLACEMENT CHARGER.

    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 64 YR