MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. DREAMSTATION 1; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Cyst(s) (1800); Nodule (4551)

Event Type  Injury  

Event Description

I experienced problems which i thought was a stroke.Hospital visit not a stroke but did locate a growth in the lungs.It was scanned had a biopsy and at that time was not cancer! i have been using a dreamstation 2 and was not aware of any problems with the machine or that i should be looking for any! this after using the dreamstation 1 which had problems! so now i am pretty upset with the health problems and more now that i find out the dreamstation 2 may also be affected.Why were people using this replacement machine not made aware or potential problems.I find it totally appalling! i also have polyps in my left nostril likely there long before i became aware of it.Now i want to know if this could be associated with using the replacement machine.I want the fda (food and drug administration) to make some kind of announcement to users of the dreamstation 2.I also want philips to acknowledge there is problems and do something about it.It is not okay to put people at risk not once but twice.I want to be contacted and i will be posting the report i read everywhere.I am sure many users have not been advised of the problems with the dreamstation 2! please advise what is happening is the machine a threat to my health am i better off not using it is it causing my health problems.I am extremely unhappy with philips my cpap (continuous positive airway pressure) doctors and technicians for not informing patients.Unless they are not aware of a problem! i want answers for myself and all the other users! why were users of philips dreamstation 2 not made aware of potential problems.Why has the fda not publicized the warnings or done yet again another recall? are any of the dreamstation products by philips safe to use? reference report: mw5153908.

• Brand Name: DREAMSTATION 1
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 19126767
• MDR Text Key: 340544864
• Report Number: MW5153909
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE 5MG; ASPIRIN 81MG; CENTRUM PROBIOTIC; PANTOPRAZOLE 40MG; QUINAPRIL 10MG; SALBUTAMOL SULPHATE 125MG; SYNTHROID 125MG; TEVA-BUDESONIDE 0.5MG; VITAMIN D3 OMEGA ; VITAMIN K2
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White