MAUDE Adverse Event Report: RESMED CORP. AIRFIT P10 MASK FOR USE WITH CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Complete Blockage (1094); Moisture or Humidity Problem (2986)

Patient Problems Nausea (1970); Suffocation (2088)

Event Date 05/22/2019

Event Type  malfunction  

Event Description

Over past month, waking from sleep during cpap use with a suffocating feeling plus nausea.No problem with this mask in warmer weather, but mask vents appeared to be completely blocked due to ordinary / expected levels of condensation in tube with cooler weather.Hard to reliably prevent this given fluctuations in room temperature / humidity in local area - other masks i have used do not seem to lose venting.I am concerned about buildup of co2 from my exhalation to potentially dangerous levels.Likely inhaling too much co2.Fda safety report id# (b)(4).

• Brand Name: AIRFIT P10 MASK FOR USE WITH CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 8655398
• MDR Text Key: 146698569
• Report Number: MW5087006
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Other
• Patient Age: 46 YR
• Patient Weight: 91