(b)(4).The f&p 950 respiratory humidifier is not currently available for sale in the united states.The f&p mr850 respiratory humidifier is an equivalent device currently on the market in the us.The 510(k) for that product is k110019.Results: evaluation of the device log file of the complaint f&p 950 respiratory humidifier revealed that the low temperature alarm occurred due to the dryline, and expiratory limb were incorrectly connected in reverse at the flow meter/ventilator end.Conclusion: the reported event was due to a user error whereby the dry line and expiratory limb were connected in reverse at the flow meter/ ventilator end.In this instance, the patient continued to receive gas flow; however, no humidity was provided.Respiratory humidifiers are part of the ventilation system which deliver medical gases to mechanically ventilated patients.As such, respiratory humidifiers are required to comply with the gas connection ports specified in the current ventilator standard iso 80601-2-12:2011 (essential performance for ventilators).This standard specifies both gas connection ports to be 22 mm male connections, which comply with iso 5356-1:2015 (breathing circuit conical connectors) for medical tapers.Due to this, the prevention of reversed connections is highly dependent upon the user.The risk control applied across all devices is by providing step-by-step instructive diagrams of the correct set up.The user instructions that accompany the f&p 950 respiratory humidifier breathing circuits provide step-by-step instructive diagrams on the correct set up of the breathing circuit limbs.The f&p 950 adult ventilator circuits have been designed with an inspiratory limb, expiratory limb, and dryline that have different colors to differentiate between the direction of gas flow.However, there remains an element of user dependency for correct set up by complying with the user instructions.The user instructions include the following warnings and cautions: "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times." "prolonged exposure to reduced humidity will result in patient harm including decreased mucociliary clearance".
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