(b)(4).Method: the complaint rt040m hospital full face mask was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Therefore, our investigation is based on the information provided by the customer, previous similar investigations and our knowledge of the product.Results: the hospital staff reported that the masks may have been overtightened to avoid all leaks.A lot check could not be carried out as the lot information was not provided by the customer.Conclusion: based on the information provided, the problem reported by the customer was most likely due to overtightening of the mask.If the mask was returned it would have been visually inspected for any damage or malfunction that may cause or contribute to the reported event.The user instructions that accompany the rt040m hospital full face mask state: "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."; "if the patient experienceds skin irritations, consult physician." since the reported incident a fisher & paykel healthcare representative has visited the hospital a number of times and is working with the hospital staff on scheduling a time to provide additional training on the correct setup and use of the rt040m hospital full face mask.
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