BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNILIM ANESTHESIA CIRCUIT

    MDR report key: 752414 · Received November 4, 2005

    Report

    Report Number
    2028807-2005-00001
    Event Type
    Malfunction
    Date Received
    November 4, 2005
    Date of Event
    October 7, 2005
    Report Date
    November 2, 2005
    Manufacturer
    WESTMED, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT CODE 8235 LOT#13381 WAS PRODUCED 12/29/2004. THE DHR REVIEW DID NOT REVEAL ANY MFG DISCREPANCIES. A REVIEW OF THE COMPLAINT DATA BASE REVEALED ONE SIMILAR REPORT INVOLVING THIS PRODUCT CATEGORY RECEIVED 8 MONTHS PRIOR TO THIS REPORT. AT THAT TIME, THE QC TEST METHODS WERE REVISED TO INCLUDE A 100% OCCLUSION AND VISUAL INSPECTION. WE HAVE NOT EXPERIENCED ANY REPORTED DEFECT SINCE THE TEST METHODS WERE REVISED. THE INSTRUCTIONS FOR USE STATE "FOLLOW THE INSTRUCTIONS PROVIDED BY THE MFR OF THE BREATHING MACHINE FOR PROPER TESTING AND INSTALLATION OF THE CIRCUIT. ENSURE ALL CONNECTIONS ARE SECURE." THE RETURNED SAMPLE WAS TESTED IN ACCORDANCE TO OUR CURRENT TEST METHODS AND FAILED THE OCCLUSION TEST. WE ARE CONFIDENT THAT THIS IS AN ISOLATED OCCURRENCE BASED ON THE IMPLEMENTATION OF THE QC TEST METHODS. WE BELIEVE IF THE CLINICIAN HAD TESTED THE CIRCUIT PRIOR TO USE, THE INCIDENT WOULD NOT HAVE OCCURRED.

    Description of Event or Problem · 1

    REPORTED THE INNER TUBE OF THE CIRCUIT WAS TWISTED. THE CLINICIAN DETERMINED THE PT WAS NOT RECEIVING ANY GAS. THE CLINICIAN REPLACED THE CIRCUIT AND MACHINE WITH NO FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNILIM ANESTHESIA CIRCUIT UNILIM ANESTHESIA CIRCUIT CAI WESTMED, INC. NA 13381

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention