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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.
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Type of DeviceVENTILATOR
Manufacturer (Section D)
MDR Report Key7214823
MDR Text Key98223602
Report NumberMW5074750
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
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 Received01/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAIRFIT N20 LARGE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/23/2018 Patient Sequence Number: 1