(b)(4).Method: the complaint rt040 vented full face mask had been destroyed at the hospital facility and was not returned to fisher & paykel healthcare for further investigation.Our analysis is accordingly based on the event description, additional information provided by the hospital and our knowledge of the product.Conclusion: the hospital staff reported that the patient developed a pressure sore after an estimated 48 to 72 hours of use and was admitted to the emergency department.On (b)(6) 2018, the patient was diagnosed with grade 3 pressure sores.The patient's injuries healed fully before being discharged from the hospital.It is acknowledged that there is an inherent risk of side effects for non-invasive ventilation, including pressure sores or irritation.Since the reported incident, the f&p representative reached out to the hospital to provide further training for the correct fitting of the f&p hospital masks.The user instructions that accompany the rt040 vented 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 experiences skin irritations, consult physician.
|