MAUDE Adverse Event Report: RESMED PTY LTD AIRFIT N30 CUSHION MEDIUM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 64214

Device Problems Improper Flow or Infusion (2954); Inadequate Instructions for Non-Healthcare Professional (2956); Patient Device Interaction Problem (4001)

Patient Problems Dry Eye(s) (1814); Pain (1994); Blurred Vision (2137)

Event Date 05/15/2023

Event Type  Injury  

Event Description

This morning when i woke up it took a few long moments to see clearly again.I was up out of bed turned on my bedroom light that is about 7 feet away and then noticed i could not see other than light and color clouds.Blinked and rubbed eyes and my vision came back.I do still have a tender spot under my left eye.The message from the machine was great seal overnight (unknown if that means no leaks or reduced leaks or increase one sleep session from 3 hours to 5 hours uninterrupted).But i woke up and my mask crooked and i think the strapped must of caught the lower orbicularis oculi muscle (looked up on google).There are no visible exterior bruises.Just feels painful maybe pain level 2.If the machine turned off during long term mask leaks, i would just wake up (i know this from power outages, when the power goes out i wake up because the machine is off).But the machine just keeps blowing this creates a possibility of drying out my eyes and causing damage (maybe possibly (it is my concern).This has been a concern of mine for a couple of years.That the machine is drying my eyes at night when there are small or any kind of leaks that blow the air upwards to my eyes.About 12 months ago i did try to use eye drops to relieve some dry eye symptoms such blurry vision (eye drop brand was systane either complete micro-lubricant? or ultra).I stopped using eye drops because of the outbreak not knowing what is safe.I do have my eyes checked every two years.I have seasonal allergies to pollen.I used to have nasal mask but that comes with its own worry and concern such as pressure ulcers (never had but a concern).I never had a problem with wind blowing into my eyes at night.I was very happy and did not want to switch to nasal pillows but my doctor stated i had to pick another mask and i think the dme stopped supplying the mask.I went to an eye doctor last week on friday (b)(6) 2023.I had trouble focusing and seeing almost double and triple.The eye doctor recommended eye drops for lubricant and seasonal allergies.Stated the mask seal breaks it can dry out eyes recommended wearing an eye mask at night.It should be a part of patient teaching to wear eye masks and use eye drops.The app states acceptable adjustment of episodes during sleep.It is possible the nasal pillows should have better ability to seal or some sort of automatic shut off should be added to the machine.I had noticing steady decline with vision and blurry and double for a while.I am allergic to pollen, so the seal breaks and rush of pollen filled air into my eyes.The app does not recommend or state maybe use another mask it just states as shown in pictures.When i went for the new mask fitting number of years ago.I really did not have choice this was the mask and the only mask.I went from a mask that was a full nasal cover mask to the nasal pillows and noticed vision problems.The doctor gave me a new prescription for eyeglasses and for the first time i was prescribed progressive lenses.Reference report: #mw5118339.

• Brand Name: AIRFIT N30 CUSHION MEDIUM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD
• MDR Report Key: 17118197
• MDR Text Key: 317174812
• Report Number: MW5118340
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 64214
• Device Lot Number: (10)1634963
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE, SYSTANE AND REMED AIR-SENSE CPAP WITH NASAL PILLOWS ; OCCASIONAL ASPIRIN, IBUPROFEN.
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White