BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1972675 · Received January 20, 2011

    Report

    Report Number
    3002158293-2011-00038
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    November 20, 2010
    Report Date
    January 11, 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 BATTERY CHARGER (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY CHARGER WAS NOT FUNCTIONAL AND WOULD NOT CHARGE THE PT'S BATTERY PACKS. THE CAUSE ON THE NON-FUNCTIONAL CHARGER WAS ISOLATED TO THE CONNECTOR PINS ON THE POWER UNIT ARE NOT MAKING A GOOD CONNECTION WITH THE CHARGER, NOT ALLOWING THE CHARGER TO POWER ON AND CHARGE THE BATTERIES. THE ROOT CAUSE OF THE CONNECTOR PINS NOT MAKING A GOOD CONNECTION WITH THE CHARGER CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE INTERMITTENT BATTERY CHARGER. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    THE PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) FEMALE PT TO REPORT THAT THE BACK OF THE CHARGER IS LOOSE. THE PT WAS SENT A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR