BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1760646 · Received July 12, 2010

    Report

    Report Number
    3002158293-2010-00719
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 22, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 OF 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

    A (B)(6) FEMALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT SERVICE TO REPORT SHE HAD ONE BATTERY ON THE CHARGER ALL DAY AND IT DID NOT CHARGE. THE PT WAS PROVIDED WITH 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 75 YR