BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1062781 · Received June 17, 2008

    Report

    Report Number
    3002158293-2008-00275
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 16, 2008
    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 HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS REPRODUCED. THE CHARGER WAS DEFECTIVE WHEN EVALUATED. THE POWER CORD CONNECTOR WAS DEFECTIVE. THE CHARGER WAS FULLY FUNCTIONAL WITH OTHER POWER CORDS. THE POWER CORD CONNECTOR WAS REPAIRED AND RESTOCKED. THE ROOT CAUSE OF THE DEFECTIVE POWER CORD CONNECTOR IS UNKNOWN BUT IS LIKELY DUE TO MISMATCH OF THE POWER CORD CONNECTOR WITH THE BASE STATION. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY CHARGER. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    THE HUSBAND OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE CONNECTOR TO THE BATTERY CHARGER IS LOOSE. HE STATED THAT WHEN HE WIGGLED IT THE BATTERY CHARGER WOULD WORK. SUPPORT SENT THE PT A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR