MAUDE Adverse Event Report: RESMED ASIA PTE. LTD. RESMED AIR 10; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 37028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Cough (4457)

Event Date 10/01/2021

Event Type  Injury  

Event Description

Coughing, nasal, nausea; i have been experiencing a chronic cough and coughing fits when using my cpap (resmed air 10) for at least a couple of months.At first, i did not equate it to using the cpap.Recently i have been experiencing nausea within an hour or two of using the cpap.I have been using the soclean 2 cleaner since i purchased it on (b)(6) 2018 from (b)(6).Fda safety report id# (b)(4).

• Brand Name: RESMED AIR 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED ASIA PTE. LTD.
• MDR Report Key: 13076994
• MDR Text Key: 282775086
• Report Number: MW5106244
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 12/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37028
• Device Lot Number: 1129330
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE ; DAILY MULTI VITAMIN ; LISINOPRIL
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White