BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2123861 · Received May 31, 2011

    Report

    Report Number
    2123861
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    January 26, 2009
    Report Date
    February 11, 2009
    Manufacturer
    WESTMED
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST WAS ATTEMPTING TO HOOK A PATIENT UP TO A DISPOSABLE PATIENT BREATHING CIRCUIT. THERE WAS AN OCCLUSION IN THE CIRCUIT. PATIENT WAS NOT ABLE TO EXHALE. MATERIAL SIMILAR TO THAT WHICH MAKES UP THE PATIENT CIRCUIT WAS CREATING THE OCCLUSION INSIDE THE TUBING. A THIN SHEET OF PLASTIC HAD CREATED A COMPLETE BLOCK AT THE PATIENT WYE.====================== MANUFACTURER RESPONSE FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT, (BRAND NOT PROVIDED) (PER SITE REPORTER)======================WE HAVE HAD 2 CIRCUITS WITH THIS PROBLEM. DIFFERENT LOTS WE BELIEVE. NOT SURE BECAUSE THE HOSPITAL STAFF DOES NOT KEEP THE BAGS THE CIRCUITS COME IN. MANUFACTURER STATED OVER THE PHONE THAT A CHANGE HAS BEEN MADE AT THE MANUFACTURING PLANT. THIS INFO CAME AFTER I CALLED TO INFORM THEM OF THE 2ND EVENT. I REQUESTED A FORMAL RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DISPOSABLE ANESTHESIA BREATHING CIRCUIT CAI WESTMED * 01411 IS LOT OF SIMILAR CIRCUI

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES