BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1996936 · Received February 20, 2011

    Report

    Report Number
    9611451-2011-00082
    Event Type
    Malfunction
    Date Received
    February 20, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 25, 2011
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED RT235 INFANT BREATHING CIRCUIT WAS PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: A LEAK WAS FOUND AT THE SWIVEL Y-PIECE, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100624. CONCLUSION: 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. THE TWO PARTS THAT MAKE UP THE SWIVEL Y-PIECE 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. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE FOLLOWING TO THE (B)(4): "WHEN VENTILATOR BEING SET UP CIRCUIT FAILED LEAK TESTING." THIS WAS OBSERVED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    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 100624

    Patients

    Seq Age Sex Outcome Treatment
    1