BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1047814 · Received May 16, 2008

    Report

    Report Number
    3002158293-2008-00203
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    March 28, 2008
    Report Date
    May 15, 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 MANUFACTURE DATE: BATTERY PACK - 02/2008, THE OTHER BATTERY PACK - 02/2008. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF TWO BATTERY PACKS HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE BATTERY PACKS NOT CHARGING WAS DEFECTIVE BATTERY CELLS WITHIN THE BATTERY PACK. THE ROOT CAUSE OF THE DEFECTIVE CELLS IS NOT KNOWN, BUT WAS PROBABLY DUE TO EXCESSIVE DISCHARGING. THERE WERE MANY "BATTERY RUNTIME EXPIRED" FLAGS ON THE DOWNLOAD FROM THIS PATIENT. THIS MEANT THAT THE BATTERY PACK WAS USED FOR GREATER THAN TWENTY FOUR HOURS. THIS MEANS THAT THE PATIENT CONTINUED TO USE A DEPLETED BATTERY FOR HOURS AFTER THE EXPIRED RUNTIME ALARM SOUNDED. THE DEFECTIVE CELLS WERE REPLACED. THE BATTERY PACKS WERE RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE FAULTY BATTERY PACKS. THE PATIENT RECEIVED REPLACEMENT BATTERY PACKS.

    Description of Event or Problem · 1

    THE DAUGHTER OF A FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER MOTHER'S BATTERY PACKS WERE DISPLAYING THE "BATTERY NEEDS SERVICE" LED ON THE CHARGER. NEITHER BATTERY PACK WOULD POWER UP THE MONITOR. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO THE PATIENT TO REPLACE THE 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 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR