BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT CIRCUIT-90" EXP

    MDR report key: 971246 · Received February 13, 2007

    Report

    Report Number
    1423395-2007-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2007
    Date of Event
    August 15, 2006
    Report Date
    January 31, 2007
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    CAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DATABASE SEARCH FOR THIS PRODUCT FOUND ONE REPORT DATED 11/17/05 FOR THIS CUSTOM PRODUCT. IT WAS A GENERAL REPORT FOR DISCONNECTS AND THERE WERE NO REPORTS OF ADVERSE PT INCIDENTS. AT THE TIME OF THE REPORT, THE CIRCUIT WAS RE-EVALUATED WITH THE CUSTOMER. IT WAS DETERMINED THAT THE TUBING REQUIRED BONDING AT THE Y JOIN DUE TO THE CUSTOMER'S DESIRED COMPONENT CONFIGURATION BEING TOO HEAVY. THERE HAVE BEEN NO OTHER REPORTS SINCE THE ABOVE ACTION.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT REC'D FROM FDA ON 01/31/07 THAT STATES THE FOLLOWING: EVENT DATE 2005. EVENT DESCRIPTION: VOLUN 2006: ANESTHESIA BREATHING CIRCUIT CAME DISCONNECTED FROM ITS OWN COMPONENTS WHILE CONNECTED TO A PT WHO WAS ANESTHETIZED AND WAS BEING MECHANICALLY VENTILATED. REPORTER NOTICED THE PROBLEM AND RECONNECTED THE CIRCUIT. THIS HAPPENED SPONTANEOUSLY, TWICE. REPORTER HAS NOT HAD THIS PROBLEM WITH OTHER BRANDS OF BREATHING CIRCUITS. NO EVIDENCE OF ADVERSE EFFECT ON PT'S HEALTH DUE TO QUICK CORRECTION OF PRODUCT PROBLEM. THIS HAS HAPPENED WITH SEVERAL OTHER CIRCUITS MADE BY MEDLINE THAT REPORTER HAS USED. VOLUN THE FOLLOWING MONTH: (EXACT SAME WORDING AS ABOVE FOR THE PREVIOUS MONTH). A CUSTOMER CONTACT WAS NOT PROVIDED IN THE MAUDE REPORT. THIS MODEL NUMBER, HOWEVER, IS A CUSTOM PRODUCT MADE FOR ONLY ONE USER FACILITY. THE YEAR WITHIN THE REPORT CHANGES FROM 2005 TO 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT CIRCUIT-90" EXP ANESTHESIA CIRCUIT CAI MEDLINE INDUSTRIES, INC. DYNJAA9760A 05AD1096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN