Result of investigation: the vyaire failure analysis laboratory performed analysis on the picture of the device, it could be observed that the tube is too long, so if it is not placed properly at the bottom of the bottle, it can provoke the failure mode reported by the customer.However, the sample is necessary to confirm that the product does not produce moisture as reported by the customer.Therefore the defect reported by the customer was not confirmed.
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Device evaluation: d10, g4, g7, h2, h6 and h10.Result of investigation: vyaire medical received one opened and decontaminated sample of p/n 441g airlife gas injection nebulizer (gin).Sample was evaluated per pqas 441g performing visual inspection and functional test, obtaining as a result that the sample is acceptable, so the defect reported by the customer was not confirmed.In question about the length of the tube p/n 037-90059 misty ox, xxl inlet tube misty ox according to dwg 037-90059 it was observed that its length is ideal for the product.However the ifu instructions for use clearly indicates that the end of the tube through which the solution entered, must be placed at the bottom of the bottle, the ifu also has the "single use" symbol and it was reported that the device was used in two patients.The root cause cannot be determined.
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