BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1214103 · Received October 24, 2008

    Report

    Report Number
    3002158293-2008-00557
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B) (4) 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 MISSING CONNECTOR 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 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 RECENT DOWNLOAD FROM A (B) (6) MALE PATIENT REVEALED "CHECK TE PAD" MESSAGES. SUPPORT CONTACTED PATIENT AND LEFT A MESSAGE. SUPPORT CONTACTED PATIENT AGAIN ON (B) (6) 2008 AND LEFT A MESSAGE. PATIENT RETURNED SUPPORT'S PHONE CALL AND REPORTED THAT HE WAS RECEIVING ALARMS. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO THE PATIENT. THE PSR FOUND THAT THE ELECTRODE BELT CONNECTOR WAS CRACKED. THE PSR GAVE THE PATIENT A REPLACEMENT 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 55 YR