MAUDE Adverse Event Report: RESMED CORP AIRSENSE 11 AUTOSET; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Lot Number 1705673

Patient Problem Sleep Dysfunction (2517)

Event Date 03/19/2024

Event Type  Injury  

Event Description

I am using resmed sleep apnea device for my condition.There is an injection molded component, a cover, used to control air flow.Under the cover component are many small holes where air is expelled.Due to distortion or tolerance stack ups the cover falls off during the night often.I have woken having problems in my heart and lung area which is an adverse side effect.I called the supplier and told them to file a report so the company could fix it.I used to work for (b)(4) and it's important that the manufacturer/designer of the equipment take prompt action.The supplier was unwilling and i can share the emails.They maintained that even with the cover fully removed device is not dangerous.That has not been my experience.Previously product lead at (b)(4).List is too long and is not pertinent.

• Brand Name: AIRSENSE 11 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 18960225
• MDR Text Key: 338501078
• Report Number: MW5153058
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1705673
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White