BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1904731 · Received November 22, 2010

    Report

    Report Number
    9611451-2010-00691
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 14, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOSPITAL ORIGINALLY ADVISED THAT THE COMPLAINT BREATHING CIRCUIT WAS NOT AVAILABLE FOR EVALUATION, HOWEVER, FISHER & PAYKEL HEALTHCARE HAS FOLLOWED-UP AND THE COMPLAINANT HAS ADVISED THAT THEY WILL RETURN THE SAMPLE FOR TESTING. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE BREATHING CIRCUIT AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH IT WAS REPORTED THAT ONE BREATHING CIRCUIT HAD LEAKED, THE HOSPITAL RETURNED TWO BREATHING CIRCUITS FOR TESTING. THE SECOND BREATHING CIRCUIT HAD A LOT NUMBER OF 100618 (DATE OF MANUFACTURE 06/18/10). METHOD: THE RETURNED RT235 BREATHING CIRCUIT WAS PRESSURE TESTED FOR LEAKS. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100618 AND NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100709. RESULTS: A LEAK WAS FOUND AT THE Y-SWIVEL PIECE OF THE TWO BREATHING CIRCUITS. 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. ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA THE MHRA (UK) THAT AN RT235 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THE LEAK TEST WAS CARRIED OUT PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA THE (B)(4) THAT AN RT235 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. 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 100709

    Patients

    Seq Age Sex Outcome Treatment
    1