(b)(4).The 950n81 neonatal ventilator dual heated circuit kit is not currently available for sale in the united states of america (usa) but it is similar to a product which is sold in the usa.The 510(k) for that product is k103767.Method: the complaint 950n81 neonatal ventilator dual heated circuit kit was not returned to fisher & paykel healthcare (f&p) for evaluation as there was no reported malfunction with the device.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that the inspiratory dryline and expiratory limb of a 950n81 neonatal ventilator dual heated circuit kit were incorrectly connected in reverse at the ventilator end.This means that the patient was receiving the prescribed pneumatic ventilation, and prescribed oxygen concentration, but was not receiving active humidification provided by the humidifier.The incorrect setup was incidentally discovered when the healthcare professional began to administer inhaled nitric oxide therapy as an adjunct therapy to help optimise conventional mechanical ventilation.Once discovered, the set-up was corrected and mechanical ventilation with inhaled nitric oxide therapy was continued.It was further reported that the patient passed away the following day due to renewed bleeding.It was later reported by the customer that the renewed bleeding was likely due to a congenital coagulation disorder.Conclusion: the reported reversed connection of the inspiratory dryline and expiratory limb at the ventilator end was due to a user error.In this instance, the patient continued to receive the prescribed pneumatic ventilation and oxygen concentration.Based on the information provided by the customer, the reported patient death was caused by "renewed bleeding" which was likely due to patient's congenital coagulation disorder.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 80601-2-12:2020 (particular requirements for basic safety essential performance of critical care ventilators).This standard specifies both gas connection ports to be 22 mm,15mm or 11.5mm male taper connections which comply with iso 5356-1:2015 (breathing circuit conical connectors).Due to this, the prevention of reversed connections is highly dependent upon the user.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, such as the f&p 950n81 neonatal ventilator dual heated circuit kit.The f&p 950 neonatal ventilator circuits, including the f&p 950n81 neonatal ventilator dual heated circuit, have been designed with expiratory limb and dryline that have different colours to differentiate between the direction of gas flow.User compliance with the instructive diagrams set out in the user instructions is necessary to ensure correct set up.The user instructions also 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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