MAUDE Adverse Event Report: RESMED CORP. RESMED AIRFIT P10 NASAL PILLOW; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The cpap nasal pillow mask builds up with moisture and blocks the exhaled air from escaping the mask leading to a buildup of co2 and rebreathers air leading to hypoxia.

• Brand Name: RESMED AIRFIT P10 NASAL PILLOW
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 18686078
• Report Number: MW5151345
• Device Sequence Number: 18211342
• Product Code: BZD
• UDI-Device Identifier: 00619498629008
• UDI-Public: 619498629008
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2024
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White