BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1082469 · Received July 22, 2008

    Report

    Report Number
    3002158293-2008-00322
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 6, 2008
    Report Date
    July 21, 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 PROBLEM WAS CONFIRMED. UPON FURTHER INSPECTION, THE ELECTRODE BELT CONNECTOR PLASTIC WAS COMPLETELY MISSING. THE PINS WERE COMPLETELY INTACT AND STRAIGHT. THE CONNECTOR COULD NOT BE SCREWED IN WHICH ALLOWED FOR AN INTERMITTENT CONNECTION BETWEEN THE MONITOR AND THE ELECTRODE BELT. THE ROOT CAUSE OF THE BENT PINS WAS PROBABLY EXCESSIVE FORCE APPLIED TO THE CONNECTOR DURING MATING. THE CONNECTOR WAS FORCED INTO THE MONITOR WHICH DEFEATED THE CONNECTOR KEYING MECHANISM AND ALLOWED THE PLASTIC TO BREAK. THE DAMAGED ELECTRODE BELT CONNECTOR WAS REPLACED. THE ELECTRODE BELT WAS RETESTED AND THEN RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A MAL PATIENT LEFT A VOICE MAIL MESSAGE INDICATING THAT HE IS RECEIVING CONSTANT ALARMS AND "THE SCREW PART PULLED AWAY FROM THE WIRE". SUPPORT CALLED PATIENT BACK 8 MINUTES LATER AND LEFT A VOICE MESSAGE (VM). SUPPORT TRIED AGAIN 12 MINUTES LATER AND THERE WAS NO ANSWER. SUPPORT CONTACTED THE PATIENT AGAIN 14 MINUTES LATER AND LEFT VM. SUPPORT CONTACTED PATIENT AGAIN APPROXIMATELY 2 HOURS LATER AND LEFT VM. PATIENT CALLED BACK APPROXIMATELY ONE HOUR LATER AND STATED THAT THE SCREW COLLAR SEEMS TO NOT BE TIGHT AND APPEARS TO BE LOOSE. HE ALSO STATED THAT HE WAS GETTING CONTINUOUS CHECK BELT MESSAGES. A LIFECOR TERRITORY MANAGER (TM) VISITED THE PATIENT AND REPLACED 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 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR