(b)(4).Method: one of the complaint device mr290v vented autofeed humidification chamber was received at fisher & paykel healthcare (f&p) new zealand where it was visually inspected.Results: visual inspection revealed that the base of the chamber dome was deformed.No other damage was observed to the chamber dome.Conclusion: we are unable to determine what may have caused the reported event, however the deformity of the base most likely indicate that transport or storage related damage had occured.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber 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.The subject mr290v chambers would have met the required specification at the time of production.The user instructions that accompany the mr290v 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." - "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occassions, could lead to a loss of ventilation pressure." - "set appropriate ventilator alarm." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".
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