MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD EVORA FULL FACE MASK; CPAP/BPAP FACE MASK

Model Number EVF1LU

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that "the tip of a patient's nose is collapsing".The healthcare facility reported that the patient had a septoplasty over 10 years ago and has been using an evora full face mask.F&p has requested further information in relation to this event.

Manufacturer Narrative

(b)(6).Fisher & paykel healthcare have requested for further information about the reported event.We will provide a followup report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that "the tip of a patient's nose is collapsing".The healthcare facility reported that the patient had a septoplasty over 10 years ago and has been using an evora full face mask.Fph requested for further information about the reported event from the customer on several occasions.No additional information was provided.

Manufacturer Narrative

(b)(4).Method: the complaint evora full face mask was not returned to fph for evaluation.Our investigation is based on the initial information provided by the healthcare facility, knowledge of our product, as well as the clinical opinion obtained from an independent medical expert.Results: the healthcare facility reported that the "tip of the patient's nose is collapsing" and that the patient had a septoplasty over 10 years ago and had been using an evora full face mask.Multiple attempts were made to obtain further information from the customer, however no additional information was received.The complaint evora full face mask was not returned for evaluation.Based on the initial information provided by the customer there was no indication of any specific fault or malfunction with the evora full face mask.The evora full face mask is a prescription only device and should be selected and fitted with the guidance of a healthcare professional based on individual patient needs.The evora full face mask is designed to rest below the nose and fits around the nasal aperture, applying minimal pressure to the sides of the nose.A clinical opinion was sought by fph from an independent medical consultant with respect to the described event.Based on the limited information available, the consultant advised that in their opinion, it is an extremely unlikely scenario where the application of a cpap mask would cause damage to nasal cartilage, which provides structural support.Conclusion: the complaint device was not returned and without further information we are unable to confirm the exact cause of the reported event.There have been no other similar events reported with use of the evora full face mask.The user instructions which accompany the evora full face mask include the following warnings: warnings: - discontinue use if discomfort or irritation occurs, and consult your healthcare provider.

• Brand Name: EVORA FULL FACE MASK
• Type of Device: CPAP/BPAP FACE MASK
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 96218 ; 8007923912
• MDR Report Key: 18014494
• MDR Text Key: 326642056
• Report Number: 9611451-2023-01004
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K212371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EVF1LU
• Device Catalogue Number: EVF1LU
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other