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

Patient Problems Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)

Event Date 01/24/2024

Event Type  Injury  

Event Description

Reporter calling, stating his resmed airsense 11 produced an error message about the "heating supply not working".Reporter states he contacted the medical supply company, aerocare, about the error message received on the device and was told the machine would need repaired.Reporter states that aerocare supplied him with a previously used "rental" unit while they were repairing his device, and reporter was provided this unit on (b)(6) 2024.Reporter states that when this rental unit was taken off of the shelf, it appeared "dusty and dirty" and that an employee at aerocare proceeded to casually wipe the device, however reporter states he had overall sanitary concerns with this rental unit after seeing its condition when it was presented to him.Reporter states he was concerned about using this previously used device, however had no other option since they now had his original machine for repairs.Reporter states he prepared the device for use that evening, and when he turned the rental unit on it "smelled like a moldy, wet ashtray".Reporter states he tried to let the machine air out but this did not help very much and the device continued to smell.Reporter states he used the device, and woke up on (b)(6) 2024 with "burning eyes, congestion" and states that half of his face is swollen.Reporter states he will be contacting his physician today regarding these symptoms.Reporter states the rental unit he was provided from aerocare is also a resmed machine "made in singapore" with "fcc id: 2achl-air11m1" and "device number 953".Reporter states he is concerned with the overall quality and sanitary measures at aerocare.Reporter states the address is: (b)(6).Reference report: mw5150702.

• Brand Name: RESMED AIRSENSE 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 18586600
• MDR Text Key: 333957319
• Report Number: MW5150701
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male