MAUDE Adverse Event Report: RESMED AIRLIFT N20 VENTILATOR

Model Number AIRFIT N20 LARGE

Device Problems Inadequacy of Device Shape and/or Size (1583); Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2017

Event Type  Injury  

Event Description

Resmed cpap mask airfit n20 only has one size head gear to fit around users ranging from small medium and large.The head gear only has 1 1/4 inch slack in the adjustment as i need a large; the head gear was impossible to adjust to where it fit me.Neither resmed maker (b)(6) nor (b)(6) medical supplies (b)(6) can resolve this problem without me buying a different head gear from them.As i explained to them it's like buying a large shoe and being sent a small shoe.I am at risk of serious injury from not using my cpap machine at night as i stop breathing for long periods.It is really bad when you buy a large product and they send you a small size.Their product information gives three different sizes and product numbers for the head gear and yet they admit they only send out one size and say it's not their problem.Please take this seriously as i am retired on a fixed income and spending more money on an f20 that i am told may fit is not an ideal solution when it is their problem.You should issue a recall of their airlift n20 mask from resmed as it is not fit for proper use.

• Brand Name: AIRLIFT N20 VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESMED
• MDR Report Key: 7214823
• MDR Text Key: 98223602
• Report Number: MW5074750
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AIRFIT N20 LARGE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 104