MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION 2 CPAP DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problems Nonstandard Device (1420); Device Emits Odor (1425); Product Quality Problem (1506); Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Nausea (1970); Cough (4457)

Event Date 10/11/2021

Event Type  Injury  

Event Description

I received a new, replacement cpap machine from philips on (b)(6) 2021, following their recall.It is a dreamstation 2 device.I confirmed with my respiratory supplier, reliable respiratory in (b)(6) that it had been set up and was ready to use.I followed the instructions, washed the water chamber and tube as recommended.That night i went to bed using the new machine.Upon turning on the device i notice a very strong smell coming from the hose.I thought this maybe a "new machine smell" and continued to use it.The following night the smell was so overpowering , causing me to cough heavily, feel nauseous and generally struggling to breath.It smells like an electrical burning smell.I got up, disconnected the machine and reverted back to my old dreamstation 1 machine.The next day i contacted philips, my pulmonary doctor, my respiratory company and the fda dme group to notify them of this offensive smell.I have since called philips again and am still waiting for a response from them.The fda person advised me to file a complaint and sent me this link.I now have two suspect machines and am getting nothing but mixed messages from medicare, cms, the fda, my health care providers, my insurance company, (b)(6).I am not getting any response from philips.I need a safe and reliable cpap machine to keep my severe osa under control.The regulations from medicare/cms are confusing and are being interpreted differently around the country.I have had mu ds 1 for nearly 4 years now but am told it cannot be replaced with a different vendor machine for another year.My local tv station in (b)(6) said this had been relaxed to 3 years due to the recall.What is the real answer? i am just one of millions of people who rely on a cpap machine to sleep well at night.I, like others, should be able to get a safe and reliable machine to replace our philips devices, regardless of how long we have had one or who is the manufacturer.In addition i now have a new philips ds 2 machine with this awful smell.Is this a more widespread problem? it needs to be addressed immediately.I have to add the quality of the ds2 looks poor compared to my original ds 1.I, and my colleagues, need a combined effort to get new machines as quickly as possible and before people get even more sicker from using these suspect machines.So far, the response from all regulatory bodies, insurance companies and, most of all, philips, is abysmal.You can contact me via my mobile, (b)(6) i hope to hear from someone soon.(b)(6).No testing has been conducted by myself.Fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAMSTATION 2 CPAP DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12751156
• MDR Text Key: 280456417
• Report Number: MW5105124
• 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: 11/01/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: NOT KNOWN
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White