BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3943076 · Received July 18, 2014

    Report

    Report Number
    9611451-2014-00634
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT380 BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT380 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: NO DAMAGE WAS FOUND TO THE BREATHING CIRCUIT OR DRYLINE DURING THE VISUAL INSPECTION. THE PRESSURE TEST CONFIRMED THAT THE BREATHING CIRCUIT WAS WITHIN SPECIFICATION AND WAS NOT LEAKING. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT CAUSED THE LEAK AS REPORTED BY THE CUSTOMER AS NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT CIRCUIT. ALL RT380 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. IN ADDITION, TUBE WEIGHING AND BOND STRENGTH TESTING ARE PERFORMED EVERY 15 MINUTES. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THE USER INSTRUCTIONS SUPPLIED WITH THE RT380 BREATHING CIRCUIT STATE: 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 THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE LEAK TEST ON TWO DIFFERENT VENTILATORS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE LEAK TEST ON TWO DIFFERENT VENTILATORS.THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421858 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 1310160304

    Patients

    Seq Age Sex Outcome Treatment
    1