BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE ADULT BREATHING CIRCUIT

    MDR report key: 5958945 · Received September 17, 2016

    Report

    Report Number
    9611451-2016-00574
    Event Type
    Malfunction
    Date Received
    September 17, 2016
    Report Date
    September 1, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT 900MR810 ADULT EVATHERM REUSABLE BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. THE RETURNED BREATHING CIRCUIT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A TEAR IN THE FILM NEAR THE CHAMBER END CUFF OF THE COMPLAINT CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 160126. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE NOTED ON THE RETURNED 900MR810 BREATHING CIRCUIT. THE CUSTOMER HAS CONFIRMED THAT THE SUBJECT BREATHING CIRCUIT WAS IN USE FOR A FEW DAYS BEFORE THE REPORTED DAMAGED WAS OBSERVED. 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 CIRCUIT WAS 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. CLEAN CIRCUIT PRIOR TO USE AND AFTER EACH PATIENT USE, USING APPROVED DISINFECTION METHODS ONLY. USE OF UNAPPROVED CLEANING METHODS MAY DAMAGE THE CIRCUIT AND REDUCE IT USEABLE LIFE. SET APPROPRIATE VENTILATOR ALARMS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN 900MR810 REUSABLE ADULT BREATHING CIRCUIT WAS TORN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610199 REUSABLE ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD 900MR810 2100021204

    Patients

    Seq Age Sex Outcome Treatment
    1