BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1053418 · Received May 28, 2008

    Report

    Report Number
    3002158293-2008-00225
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 27, 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 MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEVICE WAS ALARMING "ADJUST BELT") WAS CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM WAS INTERMITTENT SOLDER CONNECTIONS ON THE J103 CONNECTOR ON THE CA BOARD. J103 IS ONE OF THE CONNECTORS THAT BRINGS ECG INPUT FROM THE AUXILIARY BOARD PORTION OF THE MONITOR. THE INTERMITTENT CONNECTIONS WERE MAKING THE MONITOR THINK THAT THERE WAS A PROBLEM WITH THE ECGS. THE ROOT CAUSE OF THE INTERMITTENT SOLDER CONNECTIONS IS UNK, BUT IS LIKELY A MANUFACTURING DEFECT. THE MONITOR WAS REPAIRED, RETESTED A RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE J103 FAILURE. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING "ADJUST BELT" MESSAGES. SUPPORT SUGGESTED THAT HE CHECK ALL ELECTRODES FOR PROPER CONTACT WITH THE SKIN. THE PT THEN HUNG UP ON SUPPORT. THE PT CALLED BACK A SHORT TIME LATER AND STATED THAT THE ALARMS WERE CONTINUING. SUPPORT HAD THE PT PERFORM A MANUAL RECORDING AND DOWNLOAD. THE DOWNLOAD WOULD NOT GO THROUGH BECAUSE THE HOSPITAL REQUIRED A "9" TO DIAL OUT. A LIFECOR TERRITORY MANAGER (TM) VISITED THE PT AND DOWNLOADED. THE MANUAL RECORDINGS APPEARED NORMAL. THERE WAS EXCESSIVE FALL OFF ON ALL LEADS DESPITE THE CLEAN MANUAL RECORDINGS. SUPPORT HAD THE TM GIVE THE PT A SMALLER GARMENT. THE 'ADJUST BELT" MESSAGES CONTINUED. THEN THE TM SWAPPED THE ELECTRODE BELT AND THE "ADJUST BELT" MESSAGES CONTINUED. THE TM TRIED A NEW MONITOR AND THE PT DID NOT RECEIVE ANY MORE "ADJUST BELT" MESSAGES.

    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 60 YR