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

Device Problems Nonstandard Device (1420); Device Emits Odor (1425)

Patient Problems Aspiration/Inhalation (1725); Malaise (2359); Sore Throat (2396); Unspecified Respiratory Problem (4464)

Event Date 08/20/2022

Event Type  malfunction  

Event Description

This complaint is about philips dreamstation 2 auto cpap advanced machine, supplied in replacement of their recalled dreamstation cpap machine as per their confirmation no (b)(4).Particulars of this replaced machine, received by me on (b)(6) 2022 are ref dsx620h11c, sl (b)(4).I started using it on (b)(6) 2022 and have noticed that the air that it supplies through the cpap mask, is not odor free, has some smell, which is more pronounced when during the night i shut off the machine to go to bathroom and start using it again after about 3-4 minutes.It is causing a slight irritation in my throat.I also a feel a bit heavy in my head in the morning when i wake up.Because of use of old recalled cpap machine my lungs and windpipe were affected.They took about 4-5 month to heal, after i stopped using it.Afraid of similar damage by this new machine which is emitting this odor and have to discontinue using this new replaced machine.It may have issues similar to their other products that are being recalled because of some plastic problems or some other health affecting issue.Investigation of this complaint (about the odor) and finding a solution will take long time.Philips took almost a year to provide me this defective replacement and in the meantime my health deteriorated.While my complaint about odor is being investigated, cpap being almost life supporting, philips should be asked to immediately arrangement for an alternative machine ¿ at least to reimburse me for renting one out as an interim arrangement.Fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAMSTATION 2 AUTO CPAP ADVANCED MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15362653
• MDR Text Key: 299379520
• Report Number: MW5111867
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE BESYLATE 5 MG; B COMPLEX; CPAP MACHINE; HIGH ABSORPTION MAGNESIUM (OCCASIONALLY); L-LYSINE; LOSARTAN POTASSIUM 50 MG; TAMSULOSIN HCL 0.04 MG.; VITAMIN D3
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian