BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1011953 · Received March 11, 2008

    Report

    Report Number
    3002158293-2008-00092
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    November 28, 2007
    Report Date
    March 10, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE MONITOR HAD A DEFECTIVE RESPONSE BUTTON. THE REAR RESPONSE BUTTON WOULD STICK INTERMITTENTLY. THE MONITOR WAS REPAIRED. THE MONITOR WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE RESPONSE BUTTON FAILURE IS THE METAL DOME STAYING IN THE COLLAPSED CONVEX SHAPE RATHER THAN RETURNING TO ITS NORMAL CONCAVE SHAPE. THE CAUSE OF THE COLLAPSED DOME WAS DETERMINED TO BE DELAMINATION OF THE SPACER LAYER WITHIN THE SWITCH. NO ADVERSE EVENT RESULTED FROM THE FAULTY RESPONSE BUTTON.

    Description of Event or Problem · 1

    LIFECOR CUSTOMER SUPPORT NOTICED MANY "ABNORMAL SHUTDOWNS", "GEL RELEASE", "BELT UNUSABLE" AND "SERVICE CODE 6" FLAGS IN A DOWNLOAD FROM A FEMALE PATIENT. THE "GEL RELEASE" AND "BELT UNUSABLE" FLAGS LOOK TO BE ASSOCIATED WITH THE REMOVAL OF THE ELECTRODE BELT FROM THE MONITOR. THE "SERVICE CODE 6" LOOKED TO BE ASSOCIATED WITH THE PATIENT HOLDING THE RESPONSE BUTTONS BEFORE BEING PROMPTED TO AT START-UP. SUPPORT CONTACTED THE PATIENT TO REPLACE THE MONITOR . ON 11/29/2007, THE PATIENT CONTACTED SUPPORT BECAUSE OF A VOICE MAIL THAT WAS LEFT FOR HER ON THE DAY BEFORE. SHE STATED THAT SHE HAS NEVER DISCONNECTED THE ELECTRODE BELT, AND THAT SHE HAS NOT HAD ANY ALARMS. SUPPORT ASKED FOR ANOTHER DOWNLOAD TO SEE IF PROBLEMS CONTINUED. PATIENT SUCCESSFULLY DOWNLOADED ON THE FOLLOWING MONTH. THERE WERE A COUPLE MORE "ABNORMAL SHUTDOWNS" AND A COUPLE "MULTIPLE AXIS TIMEOUTS" FLAGS. THE RECORDING PERFORMED BY THE "MULTIPLE AXIS TIMEOUTS" FLAGS APPEAR CLEAN BUT THE MORPHOLOGY LOOKED DIFFERENT FROM THE BASELINE. MULTIPLE ATTEMPTS WERE MADE TO GET A PATIENT SERVICES REPRESENTATIVE (PSR) TO THE PATIENT. IN EARLY 2008, THE ACCOUNT COORDINATOR FOUND OUT THAT THE PATIENT WAS IN THE HOSPITAL FOR A NON-CARDIAC RELATED PROBLEM. SHE WAS NOT WEARING THE DEVICE AND WAS ON HOSPITAL TELEMETRY. ON ELEVEN DAYS LATER, THE PATIENT DOWNLOADED AGAIN AND ALL OF THE ABOVE FLAGS HAD SEEMED TO RESOLVE THEMSELVES. PATIENT DOWNLOADED AGAIN ON APPROX TWO WEEKS LATER, AND SOME OF THESE FLAGS REAPPEARED. THE TERRITORY MANAGER WAS ASKED TO VISIT THE PATIENT. ON 02/01/2008, THE DOCTOR'S OFFICE CONTACTED THE ACCOUNT COORDINATOR TO INFORM LIFECOR THAT THE PATIENT NO LONGER NEEDED THE SYSTEM. THE TERRITORY MANAGER PICKED THE SYSTEM UP FROM THE PATIENT.

    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 68 YR