(b)(4).The rt047m vented hospital full face mask features a mask base, seal, and headgear.The mask is intended to enable noninvasive positive pressure ventilation (nppv) therapy (cpap or bi-level) to be delivered to spontaneously breathing adult patients with respiratory insufficiency or respiratory failure and have been prescribed nppv.The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.Method: the complaint rt047m vented hospital full face mask was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results:visual inspection of the complaint device revealed that no damage was found to the headgear.Conclusion: we are unable to determine the cause of the reported event as there was no fault found with the complaint device.All assembled rt047m vented hospital full face masks are 100% leak tested, and those that fail are rejected.In addition, a sampling for pull test is conducted.The subject full face mask would have met the required specifications at the time of production.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt047m vented hospital full face mask.It also states the following: ensure adequate patient monitoring is in place.Verify that the therapy device, including alarms and safety systems, are functioning correctly prior to use.The mask must be fitted and therapy established by an appropriately trained medical practitioner or care provider.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.
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