(b)(4).Method: the complaint mr290vx vented autofeed humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the photographs and information provided by the customer, and our knowledge of the product.Results: visual inspection of the photographs provided by the customer revealed a horizontal crack near the base.Water leakage was observed around the heater base unit.However, we are unable to determine the source of leaking from the provided photos.It was reported that the water leakage was caused by the crack in the chamber.Conclusion: without the complaint device, we are unable to determine what may have caused the reported fault.Every mr290vx 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 mr290vx chamber would have met the required specification at the time of production.The user instructions that accompany the mr290vx vented autofeed humificiation 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.".
|