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

Model Number 400450

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

Patient Problem Deformity/ Disfigurement (2360)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are currently attempting to obtain the complaint device for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

It was reported that a patient developed indentation around the skull whilst using the 400450 eson nasal mask headgear for obstructive sleep apnea (osa) therapy.There was no medical intervention required.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: f&p have made multiple attempts to retrieve the device and request for further information with regards to the reported event, however limited information was provided.The complaint 400450 eson nasal mask headgear was not returned to fisher & paykel healthcare new zealand for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: it was reported that a patient developed indentation around the skull whilst using the 400450 eson nasal mask headgear for obstructive sleep apnea (osa) therapy.Conclusion: without the return of the complaint device or further information from the customer, we are unable to determine the cause of the reported event.The user instructions that accompany the 400450 eson nasal mask state the following: warnings discontinue use if discomfort or irritation occurs, and consult your healthcare provider.Fitting tips do not over-tighten any of the headgear straps.

Event Description

It was reported that a patient developed indentation around the skull whilst using the 400450 eson nasal mask headgear for obstructive sleep apnea (osa) therapy.There was no medical intervention required.No further patient consequences were reported.

• Brand Name: ESON NASAL MASK
• Type of Device: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 11369415
• MDR Text Key: 233247576
• Report Number: 9611451-2021-00191
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K121597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400450
• Device Catalogue Number: 400450
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 04/11/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other