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

Device Problem Nonstandard Device (1420)

Patient Problems Bacterial Infection (1735); Itching Sensation (1943); Pneumonia (2011); Unspecified Immune System Problem (4435); Cough (4457)

Event Date 06/03/2021

Event Type  Death  

Event Description

Hi, my name is (b)(6).My husband (b)(6) died (b)(6) 2021.I just received the recall letter.He used the cpap and ozone cleaner for years i have thrown both.He continually had sinus infections and had pneumonia about 4 times which required hospitalization.He always had cough, sinus problems and itchy skin.I'm sure all of these led to his weak immune system.He died if a bacterial infection which became septic.His liver was also damaged.I am writing to just inform you that this is such disappointing notification which in my case is too late.His quality of life really suffered and if this is the cause i'm beyond upset.I know nothing can be done anymore but wanted to express my deep hurt that something that was supposed to improve his life was actually hurting him.Fda safety report id # (b)(4).

Event Description

Hi, my name is (b)(6).My husband (b)(6) died (b)(6) 2021.I just received the recall letter.He used the cpap and ozone cleaner for years i have thrown both.He continually had sinus infections and had pneumonia about 4 times which required hospitalization.He always had cough, sinus problems and itchy skin.I'm sure all of these led to his weak immune system.He died if a bacterial infection which became septic.His liver was also damaged.I am writing to just inform you that this is such disappointing notification which in my case is too late.His quality of life really suffered and if this is the cause i'm beyond upset.I know nothing can be done anymore but wanted to express my deep hurt that something that was supposed to improve his life was actually hurting him.Fda safety report id # (b)(4).

Event Description

Additional information received from a reporter on 5/11/2022 for a report number mw5107552.

• Brand Name: CPAP AIRSENSE 10 ELITE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD.
• MDR Report Key: 13560341
• MDR Text Key: 285928600
• Report Number: MW5107552
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 02/16/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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
• Patient Outcome(s): Hospitalization; Death; Other; Disability
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White