MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FULL FACE MASK; MNT

Model Number RT040

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

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.

Event Description

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.

Manufacturer Narrative

(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.

• Brand Name: FULL FACE MASK
• Type of Device: MNT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8824750
• MDR Text Key: 152169350
• Report Number: 9611451-2019-00715
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K060044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT040
• Device Catalogue Number: RT040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1