MAUDE Adverse Event Report: RESMED PTY LTD. AIRCURVE 10 ASV BIPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DN 095

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problems Chronic Obstructive Pulmonary Disease (COPD) (2237); Sleep Dysfunction (2517); Cough (4457)

Event Date 06/04/2021

Event Type  Injury  

Event Description

I received a new bipap machine on (b)(6) 2021 and shortly after my breathing and sleep quickly detreated.I had to stop using the (new resmed aircurve 10 asv) after 3 weeks and switch back to my old " same model" machine that leaks.My pulmonologist had a breathing test done on (b)(6) 2021 and i diagnosed with copd and prescribed trelegy and singulair.I was have had persistent hack and cough ever since.I believe this machine is either defective or damaged.My breathing has been severely changed since i used this machine for 3 weeks.This has affected every aspect of my life.It is my hope that the fda will examine this machine and provide me with answers too what is wrong with this machine and if this could affect other users of this type of medical device.Fda safety report id#: (b)(4).

Event Description

Additional information received from reporter for mw5106199 on 01/07/2022: this is a revision of a previously submitted form submitted on 12/17/2021.I received a new bipap machine through workers comp provider.During the use of the new machine over a 3 week period, my airway restricted my breathing and my nightly sleep dropped 7 hours to about 3 hours.My tongue started to swell so i stopped using the machine and switched my to my old (leaking) that is the same model and manufacture.(b)(4).Fda safety report id# (b)(4).

• Brand Name: AIRCURVE 10 ASV BIPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD.
• MDR Report Key: 13059873
• MDR Text Key: 282714296
• Report Number: MW5106199
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498370924
• UDI-Public: (01)00619498370924
• 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,Followup
• Report Date: 01/05/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DN 095
• Device Catalogue Number: 37215
• Device Lot Number: 1520905
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN 500 MG AS NEEDED; ALBUTEROL SULFATE 90MCG ¿ X 4 ; ASPIRIN 81MG ; CRESTOR 10MG ; FLUTICASONE ; IBUPROFEN 800MG ¿ X 2 ; NORVASC 5MG ; OMEPRAZOLE 20MG; PROPIONATE 90MCG ; SINGULAR 10MG ; TADALAFIL 10MG ; TRELEGY 100MCG/62.5MCG/25MCG ; ZESTRIL 40MG
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White