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

Device Problem Degraded (1153)

Patient Problems Aspiration/Inhalation (1725); Non specific EKG/ECG Changes (1817); Unspecified Infection (1930); Unspecified Heart Problem (4454); Swelling/ Edema (4577)

Event Date 12/01/2021

Event Type  Injury  

Event Description

Using resmed airsense 10.Without any question, the machine put out material into my lungs which resembled the machines that are currently recalled.It is unforgivable that other machines with the same material flaws are left on the open market, to cause even more harm.It took three rounds of azitromicin to help clear up the infection.I still have residual infection in eyes, ears, sinus, throat.I also now have a heart condition that was not there before, and it is irreversible and permanent.Micocardia edema and s wave deformation.My health plan changed, and is a complete joke.The provider, linncare in (b)(4), dropped the ball three times on supplies.The person taking my call just now said "yeah i used to have iehp too, they are terrible".Iehp is a plan that intends to thin the herd.I am ignored.I cannot see my regular cardiologist who wanted to perform a procedure in (b)(6) 2021.The machine they provided almost killed me.All you would have to do is take a very close look at the machines, maybe linncare would provide the machine they took it from me? this could cost millions of lives.I wonder these days, with covid being manufactured and released to kill people, if there is any point at all to reporting this? fda safety report id# (b)(4).

• Brand Name: RESMED AIRSENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 15625497
• MDR Text Key: 302014212
• Report Number: MW5112681
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: AZITHROMYCIN ; CLOPIDOGREL ; JUBILANCE; LIPITOR; LOSARTAN ; METFORMIN ; METOPROLOL ; POTASSIUM; VITAMIN D3
• Patient Outcome(s): Other; Disability
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White