BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2741942 · Received September 12, 2012

    Report

    Report Number
    9611451-2012-00618
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    August 13, 2012
    Report Date
    August 14, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS PRESSURE TESTED AND VISUALLY INSPECTED TO CHECK FOR THE REPORTED LEAK. THE RETURNED BREATHING CIRCUIT WAS SUBSEQUENTLY SUBMERGED IN A WATER BATH. RESULTS: THE PRESSURE TEST REVEALED THAT THE RETURNED BREATHING CIRCUIT EXHIBITED SIGNIFICANT LEAK. VISUAL INSPECTION IDENTIFIED THAT THERE WAS INSUFFICIENT GLUE IN THE PROXIMAL CONNECTOR OF THE EXPIRATORY LIMB. THE WATER BATH TEST HIGHLIGHTED THAT THIS WAS THE SOURCE OF THE REPORTED LEAK. A LOT CHECK DID NOT REVEAL ANY OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120419. CONCLUSION: ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION LINE. ANY BREATHING CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE PROXIMAL CONNECTOR ONLY STARTED TO LEAK ONCE IT WAS SET UP FOR USE. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS. (B)(4)..

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN RT340 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON A SERVO-I-VENTILATOR. THEY FURTHER STATED THAT THE EXPIRATORY LIMB HAD AN AIR LEAK BUT NO PIN HOLE WAS FOUND. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120419

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I-VENTIALTOR