(b)(4).Method: the (b)(4) vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290 chamber revealed one long horizontal crack line on the lower part of the dome.In addition, ink smudges were observed on the dome indicating that the complaint chamber was likely exposed to an ethanol-based solution.Conclusion: we are unable to determine the root cause of the chamber crack, however our investigation indicates that the crack is most likely due to mechanical stress.The stress source was unable to be identified.It should be noted that based on previous investigations of the mr290v chamber, exposure to ethanol-based hand sanitizer may affect the integrity of the chamber dome and can result in cracking.The mr290 chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers."."ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient."."perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."."use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilation pressure"."ensure there is water supply connected to the chamber and that water is present within the chamber"."do not use the chamber if the seals are not intact when received, or if it has been dropped.".Our user instructions that accompany the mr850 respiratory humidifier state the following: "ensure appropriate ventilator and/or patient monitor alarms are set, connections are secure and a leak test is completed before use.".
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