Ps339155 d4 correction: the lot number was corrected from 2100917188 to 190604 and 190605.Device 1: lot 190604 dom 06/04/2019 device 2: lot 190605 dom 06/05/2019 device 3-6: lot unknown, not provided.Method: three complaint mr290v vented autofeed humidification chambers were returned to fisher & paykel healthcare (f&p) in new zealand and were visually inspected.Results: visual inspection of devices 1 and 2 revealed that the returned devices had a cracked dome.It was also found that the ink of chambers 1 and 2 were smeared.There was no fault found with device 3.Conclusion: the cracked dome found with devices 1 and 2 were most likely caused by contact with an unknown solvent, as indicated by the smeared ink.Based on previous investigations of similar complaints, solvents that contains alcohol can attack dome material and subsequently cause the dome to crack.There was no fault found with device 3.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 chambers 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." - "set appropriate ventilator alarms." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".
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