BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1250041 · Received November 14, 2008

    Report

    Report Number
    3002158293-2008-00600
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 14, 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 EVALUATIONS BOTH BATTERY PACKS HAVE BEEN COMPLETED. THE BATTERY PACK WOULD NOT WORK BECAUSE THERE WAS WATER INSIDE THE BATTERY PACK. ONE OF THE CELLS WAS CORRODED UNDER THE BATTERY CONNECTOR. THE BATTERY PACK WAS SCRAPPED. THE ROOT CAUSE OF THE BATTERY PACK NOT CHARGING WAS THIS WATER DAMAGE. ANOTHER BATTERY PACK WAS GIVING THE "BATTERY PACK FAULT" LED BECAUSE IT WAS USED FOR GREATER THAN TWENTY-FOUR HOURS. THERE WERE MANY "BATTERY RUNTIME EXPIRED" FAULT FLAGS ON THE DOWNLOAD. THE BATTERY PACK WAS FULLY FUNCTIONAL. IT WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT OCCURED DUE TO THE DEFECTIVE BATTERY PACK. THE PT RECEIVED REPLACEMENT BATTERY PACKS.

    Description of Event or Problem · 1

    THE DAUGHTER OF A FEMALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT BOTH BATTERY PACKS WERE GIVING THE "BATTERY PACK FAULT" LED WHEN PLACED IN THE BATTERY CHARGER. THE PT WAS UNABLE TO DOWNLOAD BECAUSE THEY DO NOT HAVE A LANDLINE. SUPPORT SENT THE PT TWO REPLACEMENT BATTERY PACKS.

    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 69 YR