MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ESON 2 NASAL MASK

Model Number ESN2MU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint eson 2 nasal mask model is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k153505.The complaint eson2 nasal mask is en route to fisher & paykel healthcare (b)(4) for evaluation.We are also currently in the process of obtaining more information from the customer regarding the event.A follow-up report will be provided upon completion of our investigation.

Event Description

A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) representative that a patient using eson 2 nasal mask had deterioration in vision from 90% to less than 60% within the last year.It was also reported by the distributor that the patient was requested to submit certificate/letter of doctor's opinion however no confirmation was received.No further patient consequences were reported.

Event Description

A distributor in germany reported via a fisher & paykel healthcare (f&p) representative that a patient using eson 2 nasal mask had deterioration in vision from 90% to less than 60% within the last year.It was also reported by the distributor that the patient was requested to submit certificate/letter of doctor's opinion however no confirmation was received.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).The complaint eson 2 nasal mask model is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k153505.Method: the complaint eson2 interface was received at f&p new zealand for evaluation.Our investigation is based on the information provided by the customer, visual inspection of the complaint mask and our knowledge of the product.Results: a doctor's opinion was requested from the patient; however no certificate was provided.A visual inspection of the compliant device revealed that there was no physical damage or observable defects to the mask.A leak test could not be performed due to health and safety reasons as the mask base and its components (includes a diffuser, nasal seal, and headgear) are moldy, dirty and have a strong odor.Conclusion: we cannot conclusively determine what caused the reported event, however, we identify that the interface had no physical damage which might result in an air leak.The user instructions that accompany the interface eson2 nasal mask state: if you are experiencing mask leaks, you may need to lift the silicone seal off your face and reposition it again.The user instructions also contain the following warning: discontinue use and consult your healthcare provider or physician if the following occurs: 1.Mask discomfort or irritation.2.Allergic reaction.Ensure the diffuser is completely dry before each use.

• Brand Name: ESON 2 NASAL MASK
• Type of Device: MASK
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8895767
• MDR Text Key: 154754671
• Report Number: 9611451-2019-00785
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K153505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ESN2MU
• Device Catalogue Number: ESN2MU
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability