BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1372297 · Received February 19, 2009

    Report

    Report Number
    3002158293-2009-00082
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    January 12, 2009
    Report Date
    February 18, 2009
    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 EVAL OF ELECTRODE BELT (B) (4) HAS BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO HAVE AN OPEN CONNECTION IN THE DISTRIBUTION NODE. THERE WERE WIRES THAT CAME OFF A FEW SOLDER PADS. THE WIRES TO PADS. T1, T15 AND T9 WERE PULLED FROM THEIR SOLDER PADS. THIS MADE THE SYSTEM THINK THE BELT WAS NOT SITTING CORRECTLY ON THE BODY. THE TRUNK CABLE WAS PULLED THROUGH THE STRAIN RELIEF CLAMP. THE DISTRIBUTION NODE WAS REPAIRED AND THE ELECTRODE BELT WAS TESTED. BASELINE EVAL WAS PERFORMED AND THE CARDIAC SIGNAL NOW APPEARS NORMAL. THE ELECTRODE BELT WAS RETURNED TO STOCK. THE ROOT CAUSE OF THIS OPEN CONNECTION IS LIKELY DUE TO EXCESSIVE FORCE ON THE ELECTRODE BELT CABLE. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B) (6) MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE SYSTEM IS CONTINUOUSLY ALARMING TO "CHECK PADS". THE PT'S SISTER STATES THAT THE PT IS A LARGER MAN AND MAY NEED A LARGER GARMENT. SUPPORT NOTICED THAT THE PT WAS FIT ON (B) (6) 2009 AND STILL HAS NOT RECEIVED A SECOND GARMENT. SUPPORT FELT THE PROBLEM WAS DUE TO NOT CHANGING THE GARMENT AS RECOMMENDED EVERY 2-3 DAYS. THE PT CALLED BACK AND STATED THAT THE WIRES WERE TWISTED AND HE COULD NOT GET THEM UNTWISTED. SUPPORT SENT A PT SERVICES REP (PSR) TO THE PT TO ASSESS THE PROBLEM. THE PSR STATED THAT THE PT IS A VERY LARGE MAN AND THE ECGS KEEP FLIPPING OVER WHEN HE MOVES. THE PT WAS ADMITTED TO THE HOSPITAL ON (B) (6) 2009. HE WAS PLACED ON TELEMETRY ON (B) (6) 2009, A NURSE FROM MEMORIAL REGIONAL CONTACTED SUPPORT TO REPORT THAT THE PT WAS GOING TO BE DISCHARGED. SUPPORT SENT A PSR TO THE PT TO REPLACE THE ELECTRODE BELT.

    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 66 YR