BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3943083 · Received July 18, 2014

    Report

    Report Number
    9611451-2014-00640
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 20, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. ONE CIRCUIT WAS FROM LOT 130819 (DATE OF MANUFACTURE: 19 AUGUST 2013) THE OTHER CIRCUIT WAS FROM LOT 130807 (DATE OF MANUFACTURE: 7 AUGUST 2013). THEY WERE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAK. RESULTS: VISUAL INSPECTION DID NOT IDENTIFY ANY DAMAGE TO THE RETURNED BREATHING CIRCUITS. PRESSURE TEST REVEALED THAT BOTH THE CIRCUITS WERE WITHIN SPECIFICATION. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE LEAK REPORTED BY THE CUSTOMER AS NO FAULT WAS FOUND WITH THE RETURNED BREATHING CIRCUITS. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." THE HOSPITAL STAFF CORRECTLY CHECKED THE CIRCUITS PRIOR TO PATIENT USE. THIS IS IN LINE WITH OUR USER INSTRUCTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE LEAK TEST PRIOR TO PATIENT USE. THEY FURTHER REPORTED THAT THE EXPIRATORY LIMBS WERE LEAKING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE LEAK TEST PRIOR TO PATIENT USE. THEY FURTHER REPORTED THAT THE EXPIRATORY LIMBS WERE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421522 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 130819

    Patients

    Seq Age Sex Outcome Treatment
    1