BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121035 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00373
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 17, 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

    MONITOR. ELECTRODE BELT. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR SN AND ELECTRODE BELT HAVE 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. IT IS LIKELY THAT WHEN THE PT DROPPED THE MONITOR, THE ELECTRODE BELT CAUGHT THE MONITOR BEFORE IT HIT THE GROUND. THE MONITOR WAS FULLY FUNCTIONAL. IT WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PT REC'D A REPLACEMENT ELECTRODE BELT AND MONITOR.

    Description of Event or Problem · 1

    THE WIFE OF A MALE PT LEFT A VOICE MAIL THAT THE PT WAS TREATED. LIFECOR CUSTOMER SUPPORT CALLED THE PT AND WIFE. THE WIFE STATES THAT THE PT WAS SITTING IN A CHAIR, HEARD THE ALARM, AND FELT THE TREATMENT. THE PT DID NOT HIT THE RESPONSE BUTTONS. THE PT STATED, "SOMEONE MIGHT HAVE TOLD ME HOW TO STOP IT BUT I MUST HAVE FORGOT". THE SPOUSE CALLED THE EMERGENCY MEDICAL PERSONNEL WHO CHECKED OUT THE PT. SUPPORT DISCUSSED RESPONSE BUTTON USE AND REQUESTED THAT THE PT PUT GEL ON THE THREE TREATMENT PADS UNTIL THE ELECTRODE BELT CAN BE REPLACED. SUPPORT CONTACTED THE PT AGAIN ABOUT 40 MINUTES LATER TO SEE HOW THE PT WAS DOING. THE WIFE SAID THEY WERE GOING TO THE EMERGENCY ROOM BECAUSE THE PT HAD FORGET TO TELL HER THAT HE HAD DROPPED THE MONITOR EARLIER TODAY. A LIFECOR PT SERVICES REPRESENTATIVE (PSR) VISITED THE PT AND EXCHANGED THE ELECTRODE BELT AND MONITOR. THE DOWNLOAD REVEALED TWO TREATMENT EVENTS CAUSED BY NOISE. THE PSR STATED THAT THE MONITOR APPEARS TO FUNCTION NORMALLY.

    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 69 YR