(b)(4).Method: the complaint rt040m vented hospital full face mask was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the photograph provided revealed that the seals were found partly separated from the mask bases.However, a continuous bead of glue around the mask seal on the part of the mask is visable on the photograph.The part of the seal that didn't separate from the base indicates that the seal was properly inserted.Conclusion: we were unable to determine the root cause of the observed separation.Visual inspection indicated that the masks were assembled and glued properly.This suggests that the separation occurred post production.The rt040m full face mask features a mask base, seal, and headgear.The mask seal is inserted into the mask base and is secured with glue.Each assembled mask seal is inspected to ensure it is correctly inserted and there are no unacceptable gaps between the seal and the base.Samples are taken and the mask seals are pulled apart after 24 hours to ensure they meet or exceed the required detachment force before the assembled product can be released.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt040m non-vented hospital full face mask.It also states the following: "operating pressure range: 5 - 25 cmh2o"."this mask may only be used in a hospital or clinical setting where the patient is adequately monitored by trained medical staff.Failure to monitor the patient may result in loss of therapy, serious injury or death." "in the case of therapy device failure, the use of this mask requires the same level of attention and assistance as in the use of a tracheal tube.".
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