BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1172604 · Received September 19, 2008

    Report

    Report Number
    3002158293-2008-00456
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 18, 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 EVAL OF ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT WAS FOUND TO HAVE A SHORT CIRCUIT IN ECG A. THE SHORT WAS FIXED. THE ELECTRODE BELT WAS REFURBISHED. BASELINE EVAL WAS PERFORMED AND THE CARDIAC SIGNAL NOW APPEARS NORMAL. THE ELECTRODE BELT WAS RETURNED TO STOCK. THE ROOT CAUSE OF THIS SHORT CIRCUIT IS UNK, BUT IS LIKELY DUE TO STRAIN PLACED ON THE CABLE. THE ELECTRODE BELT SHORT CIRCUIT WAS FIXED. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A FEMALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE WAS GETTING "ADJUST BELT" MESSAGES. SHE STATED THAT SHE WAS USING GEL ON THE ROUND ECGS. SUPPORT EXPLAINED THAT GEL SHOULD ONLY BE USED IF THE TREATMENT PADS RELEASE GEL AND ONLY ON THE TREATMENT PADS THEMSELVES. SUPPORT HAD THE PT REMOVE THE GEL AND TIGHTEN THE GARMENT. SUPPORT ALSO HAD THE PT DOWNLOAD WHICH REVIEWED FALLOFF ON ALL CHANNELS. SUPPORT ASKED THE PT TO CALL BACK IF ABOVE SUGGESTIONS DID NOT WORK. PT CALLED BACK ONE HOUR LATER AND STATED THAT SHE WAS STILL GETTING "ADJUST BELT" ALARMS. SUPPORT SENT A PT SERVICES REP (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 59 YR