BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS

    MDR report key: 6219290 · Received January 3, 2017

    Report

    Report Number
    3012307300-2017-00031
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Report Date
    December 13, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUIT HAD A QUALITY ISSUE, WHICH CAUSED THE CIRCUIT TO DISCONNECT INTRA-OPERATIVELY. IT WAS NOTED THAT PATIENT SAFETY WAS AT RISK DUE TO THE INCIDENT. IT WAS ADDITIONALLY REPORTED THAT THERE WAS A "MASK DISCONNECT FROM [THE] ELBOW/CIRCUIT." NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00031, 3012307300-2017-00032, 3012307300-2017-00033, 3012307300-2017-00034, 3012307300-2017-00070, 3012307300-2017-00071, 3012307300-2017-00072, 3012307300-2017-00073, 3012307300-2017-00074, 3012307300-2017-00075, 3012307300-2017-00076, 3012307300-2017-00077, 3012307300-2017-00078, 3012307300-2017-00079, 3012307300-2017-00080, 3012307300-2017-00081, 3012307300-2017-00082, 3012307300-2017-00083, 3012307300-2017-00084, 3012307300-2017-00085, 3012307300-2017-00086, 3012307300-2017-00087, 3012307300-2017-00088, 3012307300-2017-00089, 3012307300-2017-00090, 3012307300-2017-00091, 3012307300-2017-00092, 3012307300-2017-00093, 3012307300-2017-00094, 3012307300-2017-00095, 3012307300-2017-00096, 3012307300-2017-00097, 3012307300-2017-00098, 3012307300-2017-00099, 3012307300-2017-00100, 3012307300-2017-00101, 3012307300-2017-00102, 3012307300-2017-00103, 3012307300-2017-00104, 3012307300-2017-00105, 3012307300-2017-00106, 3012307300-2017-00107, 3012307300-2017-00108, 3012307300-2017-00109, 3012307300-2017-00110, 3012307300-2017-00111, 3012307300-2017-00112, 3012307300-2017-00113, 3012307300-2017-00114, 3012307300-2017-00115, 3012307300-2017-00116, 3012307300-2017-00117, 3012307300-2017-00118, 3012307300-2017-00119, 3012307300-2017-00120, 3012307300-2017-00121, 3012307300-2017-00122, 3012307300-2017-00123, 3012307300-2017-00124, 3012307300-2017-00125, 3012307300-2017-00126, 3012307300-2017-00127, 3012307300-2017-00128, 3012307300-2017-00129, 3012307300-2017-00130, 3012307300-2017-00131, 3012307300-2017-00132, 3012307300-2017-00133, 3012307300-2017-00134, 3012307300-2017-00135, 3012307300-2017-00136, 3012307300-2017-00137, 3012307300-2017-00138, 3012307300-2017-00139, 3012307300-2017-00140, 3012307300-2017-00141, 3012307300-2017-00142, 3012307300-2017-00143, 3012307300-2017-00144, 3012307300-2017-00145, 3012307300-2017-00146, 3012307300-2017-00147, 3012307300-2017-00148, 3012307300-2017-00149, 3012307300-2017-00150, 3012307300-2017-00151, 3012307300-2017-00152, 3012307300-2017-00153, 3012307300-2017-00154, 3012307300-2017-00155, 3012307300-2017-00156, 3012307300-2017-00157, 3012307300-2017-00158, 3012307300-2017-00159, 3012307300-2017-00160, 3012307300-2017-00161, 3012307300-2017-00162, 3012307300-2017-00163, 3012307300-2017-00164, AND 3012307300-2017-00165.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846 PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1