BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2021233 · Received March 16, 2011

    Report

    Report Number
    9611451-2011-00167
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BREATHING CIRCUITS HAVE NOT YET BEEN RECEIVED FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE THREE COMPLAINT BREATHING CIRCUITS WERE RECEIVED FOR EVALUATION. THE CIRCUITS WERE PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: A LEAK WAS DETECTED BETWEEN THE SWIVEL ELBOW AND Y-PIECE OF EACH BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100811. CONCLUSION: ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN (B)(4) AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE TWO PARTS THAT MAKE UP THE Y-SWIVEL ARE HELD TOGETHER BY A SNAP-FIT, WHICH HAS SOME INHERENT LEAKAGE THAT IS DETECTED AND COMPENSATED FOR BY THE VENTILATOR. IT IS POSSIBLE THAT IF NOT PROPERLY LOCKED INTO PLACE, THE LEAK BETWEEN THE SWIVEL JOINT WAS ENHANCED DURING TRANSPORT OR SETUP DESPITE HAVING PASSED THE LEAK TEST AT THE TIME OF PRODUCTION. THE RT235 USER INSTRUCTIONS 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. OUR MONITORING AND TRENDING OF INFANT BREATHING CIRCUIT SWIVEL LEAKS HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE RT235 BREATHING CIRCUITS DID NOT PASS THE LEAK TEST ON A PURITAN BENNETT 840 VENTILATOR. THE LEAK TEST WAS CARRIED OUT PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE RT235 BREATHING CIRCUITS DID NOT PASS THE LEAK TEST ON A PURITAN BENNETT 840 VENTILATOR. THE LEAK TEST WAS CARRIED OUT PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT235 100811

    Patients

    Seq Age Sex Outcome Treatment
    1 PURITAN BENNETT 840 VENTILATOR| PURITAN BENNETT 840 VENTILATOR