MAUDE Adverse Event Report: RESMED CORP RESMED AIR SENSE 10; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Aspiration/Inhalation (1725); Unspecified Respiratory Problem (4464)

Event Date 04/13/2024

Event Type  malfunction  

Event Description

Found mold in the elbow on my cpap machine connecting the hose to the mask.This may explain why my respiratory problems have gotten worse while using the machine over the last several months.I clean and replace the parts that are suggested but was never told about the elbow which cannot be taken apart to clean.No filter replacement which is where the old is growing from getting wet.

• Brand Name: RESMED AIR SENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 19143014
• MDR Text Key: 340740217
• Report Number: MW5154003
• 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: 04/16/2024

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Patient Sequence Number: 1
• Treatment: IBUPROFEN. ; IMITREX. ; IRBESARTAN. ; MAGNESIUM.; METFORMIN. ; PRILOSEC. ; ROSUVASTATIN. ; VITAMIN D.; ZYRTEC.
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White