BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 2140273 · Received June 27, 2011

    Report

    Report Number
    9611451-2011-00377
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 28, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT228 IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A DEVICE THAT IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR DEVICE IS K020332. METHOD: THE COMPLAINT DEVICES RETURNED INCLUDED THE RT228 INSPIRATORY LIMB, THE RT235 EXPIRATORY LIMB, THE SWIVEL AND THE PRESSURE LINE. THE RT228 AND RT235 CIRCUITS USE THE SAME MODEL OF SWIVEL. A VISUAL INSPECTION OF ALL RETURNED COMPONENTS WAS PERFORMED. DIMENSIONAL MEASUREMENTS OF THE SWIVEL AND THE SLE RESTRICTOR WERE TAKEN USING DIGITAL CALIPERS. A PERFORMANCE TEST WAS CARRIED OUT TO CHECK FOR TIGHTNESS OF FIT. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO ANY OF THE RETURNED PRODUCT. THE DIMENSIONAL MEASUREMENTS OF THE SLE CONNECTOR AND SWIVEL WERE WITHIN SPECIFICATION AS PER THEIR RESPECTIVE DRAWINGS. BOTH THE SLE CONNECTOR AND THE RT235 EXPIRATORY LIMB WERE ABLE TO MAKE A TIGHT CONNECTION WITH THE SWIVEL WYE. THIS IS THE ONLY COMPLAINT OF THIS TYPE THAT WE HAVE RECEIVED FOR THIS PRODUCT. CONCLUSION: THERE WAS NO DEFECT FOUND WITH THE PRODUCT. OUR USER INSTRUCTIONS CONTAIN 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT, WHILE USING AN RT228 INFANT BREATHING CIRCUIT IN CONJUNCTION WITH THE EXPIRATORY LIMB OF AN RT235 INFANT CIRCUIT, THE Y-PIECE CONNECTION WITH THE YELLOW SLE RESTRICTOR AND THE EXPIRATORY LIMB BECAME LOOSE AND HAD TO BE TIGHTENED. THIS OCCURRED DURING THE VENTILATION OF A CHILD. THERE WAS NO PATIENT CONSEQUENCE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT228 101126

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER| RT235 INFANT BREATHING CIRCUIT