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

Lot Number DN 204

Patient Problem Sleep Dysfunction (2517)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

I am writing to request a immediate investigation of resmed and their air sense 10 cpap machine.There are two parts to this request.1: resmed has a guaranteed built in profit scam with their 5 year throw away air sense 10 cpap machine.2: resmed knowledge of a defect in the machine with no desire to fix the well known problem.#1: resmed's air sense 10 has a 2 year warranty and a authorized replacement by health insurance companies of 5 years.The last 3 years resmed will give no assistance to the consumer.They supply no parts to the consumer and when contacted they only send a form email telling the consumer to use one of 2 "authorized" repair centers on the east coast.The estimated repair cost is (b)(6).Their contract with resmed does not allow them to sell parts to the end user.If you cannot afford the repair (like me) then just wait 3 more years and resmed will supply you with a new machine through your health insurance.Obviously, this is a scam.#2: resmed's air sense 10 machine has a whirling sound every time one inhales.This sound gets louder as the machine is used on a nightly basis.The noise, in my case, causes me to wake up which defeats the purposes of a cpap machine, a good night's sleep.When one researches the problem on the internet you will see many complaints with suggested solutions.3 examples if i may.One person puts their machine in a nightstand drawer and drills a hole for the hose to come through.One person built a box to quiet the machine.I have built a box out of ¾" insulation board as well as wrapping 2 bath towels around the machine.Please see attachments.Resmed is very aware of this defect but does nothing to solve this problem.I have contacted the president, ceo, and coo.The result? another form email listing their two "authorized" repair centers who have a contract with resmed to not sell any parts to the end user.The result of resmed's action most definitely sends you back to complaint #1.Please open a case on this matter.With phillips no longer selling their cpap machines in the us resmed now enjoys a monopoly on cpap machines and without the fda's help matters will only get worse.(b)(6).

• Brand Name: AIR SENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 18640509
• MDR Text Key: 334632869
• Report Number: MW5151019
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Lot Number: DN 204
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADVIL AS NEEDED ; ASPIRIN .81 VITAMINS ; B COMPLEX ; BUPROPION HCL ER XL 150MG; CLONAZEPAM .50MG 3 A DAY ; COQ10 100MG ; EZETIMIBE (ZETIA) 10MG X1 ; FISH OIL 1200MG 2X A DAY ; LAMICTAL(LAMOTRIGINE) 200MG 2X A DAY ; MELATONIN 2.5MG ¿ 5MG AS NEEDED; MULTI,C,E,D; PAXIL 30MG 1X A DAY ; ROSUVASTATIN 40MG 1X A DAY ; TURMERIC CURCUMIN 1500MG X2
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White