BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1220871 · Received October 29, 2008

    Report

    Report Number
    3002158293-2008-00565
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 29, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE BATTERY NOT CHARGING WAS DUE TO A BROKEN WIRE ON THE CELLS. THE WHITE WIRE CONNECTS THE CELLS TO THE BOARD. THE ROOT CAUSE OF THE BROKEN WIRE WAS A MANUFACTURING ASSEMBLY ERROR OF TOO MUCH SOLDER ON THIS LEAD. THE WIRE WAS REPLACED. THE BATTERY PACK WAS RETESTED AND RESTOCKED. THE ASSEMBLER WHO CREATED THIS BATTERY PACK IS NO LONGER WITH LIFECOR. NO ADVERSE EVENT RESULTED FROM THE FAULTY BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTER PACK.

    Description of Event or Problem · 1

    A FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF HER BATTERY PACK WOULD NOT CHARGE ALL THE WAY. SHE STATED THAT AFTER A COUPLE OF HOURS, IT WOULD GO FROM THE ORANGE CHARGING LIGHT TO THE RED BATTERY WITH A LINE THROUGH IT LIGHT. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO THE PATIENT TO REPLACE THE BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR