BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ANESTHESIA BREATHING CIRCUITS

    MDR report key: 3980626 · Received June 20, 2014

    Report

    Report Number
    2183502-2014-00422
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT THE ANAESTHESIA BREATHING CIRCUIT WERE DISCONNECTING, CAUSING LEAKING. IT IS UNKNOWN IF THE LEAK WAS FOUND PRIOR TO USE OR DURING USE ON A PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME. NO ADVERSE EFFECTS TO A PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364309 PORTEX ANESTHESIA BREATHING CIRCUITS CAI-CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI SMITHS MEDICAL INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK