BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-HEATED ADULT BREATHING CIRCUIT

    MDR report key: 4283055 · Received November 27, 2014

    Report

    Report Number
    9611451-2014-00849
    Event Type
    Malfunction
    Date Received
    November 27, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 31, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES RETURNED: 1 X RT134 LOT 120215 DATE OF MANUFACTURE: 15 FEBRUARY 2012, 1 X RT134 LOT 120306 DATE OF MANUFACTURE: 06 MARCH 2012. METHOD: TWO RT134 NON-HEATED ADULT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THEY WERE PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO TEST FOR LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT BOTH OF THE RETURNED CIRCUITS EXHIBITED LEAK AND WERE OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAK ON BOTH CIRCUITS WAS THROUGH THE CONNECTION BETWEEN THE LID AND BOWL OF THE INSPIRATORY AND EXPIRATORY WATER TRAPS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 120215 AND 120306. CONCLUSION: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND LID, WHICH CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT ANY LEAK MUST HAVE DEVELOPED AFTER THE BREATHING CIRCUIT WAS RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT134 NON-HEATED ADULT BREATHING CIRCUIT STATE THE FOLLOWING: "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 BREATHING CIRCUIT BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT TWO RT134 ADULT BREATHING CIRCUITS FAILED THE SERVO-S VENTILATOR LEAK TEST. THEY FURTHER STATED THAT THE LEAK OCCURRED FROM THE WATER TRAP.THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770610 NON-HEATED ADULT BREATHING CIRCUIT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT134 120215

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-S VENTILATOR