Model Number RT040 |
Device Problems
Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pressure Sores (2326)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Fisher & paykel healthcare is currently in the process of retrieving further information regarding the event.We will provide a follow up report upon the completion of our investigation.
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Event Description
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A hospital in the (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient had a grade three pressure sore with an rt040m hospital full face mask.No further patient consequence was reported.
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Event Description
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A hospital in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that a patient had a grade three pressure sore with an rt040m hospital full face mask.No further patient consequence was reported.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt040 vented full face mask 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.Result: the hospital staff reported that the patient was receiving niv therapy for 24 hours continuous treatment when the grade 3 pressure sore developed.The hospital staff also reported that the patient had received niv therapy one month prior to this event and had developed a grade 2 pressure sore at that time.Conclusion: we are unable to determine the root cause of the problem reported by the hospital staff.An inherent side effects for non-invasive ventilation includes pressure sores or irritation.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.
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Search Alerts/Recalls
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