BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121034 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00374
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 13, 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 ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE NOISE ON ALL LEADS WAS AN INTERMITTENT SHORT IN THE DISTRIBUTION NODE. THE -5V POWER SUPPLY WAS BEING LOADED TO THE -2V POWER SUPPLY. THIS CAUSED NOISE IN ALL LEADS. THE ELECTRODE BELT WAS REPAIRED, RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE SHORTED CONNECTION CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO STRAIN PLACED ON THE CABLE WHICH ALLOWED THE WIRE TO BE FORCIBLY REMOVED FROM THE SOLDER PAD. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE WAS GETTING "ADJUST BELT" AND ARRHYTHMIA ALARMS, SUPPORT ASKED THE PT WHEN WAS THE LAST TIME HE CHANGED HIS GARMENT. HE STATED IT WAS SOMETIME LAST WEEK. SUPPORT SUGGESTED THE PT CHANGE OUT THE GARMENT. PATIENT DID THIS AND WAS STILL GETTING THE ALARMS. SUPPORT TRIED TO LOCATE A PT SERVICES PRESENTATIVE (PSR) TO VISIT THE PT. THE PT CALLED BACK TO STATE THAT HE REMOVED THE SYSTEM UNTIL THE PROBLEM CAN BE RESOLVED BECAUSE IT WAS STILL ALARMING. A PSR VISITED THE PT AND EXCHANGED THE GARMENT. SHE STATED THAT THE DEVICE CONTINUED TO ALARM. THE PSR EXCHANGED THE ELECTRODE BELT. THE DEVICE STOPPED ALARMING. THE PSR REITERATED TO THE PT TO CHANGE THE GARMENT EVENT 2-3 DAYS AND HOW TO PROPERLY WASH THE GARMENTS.

    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 47 YR