BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE ADULT BREATHING CIRCUIT

    MDR report key: 5171784 · Received October 23, 2015

    Report

    Report Number
    9611451-2015-00438
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 23, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE 900MR810 REUSABLE ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE RETURNED CIRCUIT WAS VISUALLY INSPECTED AND THE BEAD WIDTH, BEAD HEIGHT, OUTSIDE DIAMETER AND FILM THICKNESS WAS MEASURED. RESULTS: VISUAL INSPECTION REVEALED THAT THE BREATHING CIRCUIT FILM WAS TORN NEAR THE CHAMBER END CUFF. MEASUREMENT OF THE BEAD WIDTH, BEAD HEIGHT, OUTSIDE DIAMETER AND FILM THICKNESS REVEALED THAT THE CIRCUIT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 141020. CONCLUSION: BASED ON THE INVESTIGATION CONDUCTED, THE DAMAGE OBSERVED TO THE RETURNED BREATHING CIRCUIT WAS MOST LIKELY CAUSED BY PHYSICAL DAMAGE IN WHICH THE CIRCUIT LIMB WAS PULLED AT THE TUBE INSTEAD OF THE CUFF. ALL 900MR810 REUSABLE ADULT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THE REPORTED DAMAGE OCCURRED AFTER THE SUBJECT BREATHING CIRCUITS WERE RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE 900MR801 REUSABLE ADULT BREATHING CIRCUITS STATE: "INSPECT CIRCUIT BEFORE RE-USE, DO NOT USE IF THE CIRCUIT SHOWS SIGNS OF DETERIORATION SUCH AS: CRACKS, TEARS OR DAMAGE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM, AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "DISCONNECT TUBE BY HANDLING END CONNECTORS ONLY, DO NOT PULL OR TWIST TUBING AS THIS MAY CAUSE DAMAGE." "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE 900MR810 REUSABLE ADULT BREATHING CIRCUIT WAS SPLIT NEAR THE CHAMBER END. THIS WAS FOUND AFTER PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700917 REUSABLE ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD 900MR810 141020

    Patients

    Seq Age Sex Outcome Treatment
    1