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

Model Number DSX620H11C

Patient Problems Hypersensitivity/Allergic reaction (1907); Sneezing (2251)

Event Date 10/15/2023

Event Type  malfunction  

Event Description

I received a replacement cpap machine last year in the philips recall.It is a dreamstation 2, sn (b)(6).After using the machine for a matter of months i began to experience severe sinus irritation.Toward the end of a night's sleep i would begin to sneeze uncontrollably.Often, this would persist throughout the day.The problem stopped when i stopped using the machine and returned when i resumed.Medications prescribed by my internist didn't help.I took the machine to the local provider, a (b)(6), for evaluation.They were unable to detect the presence of visible noxious fumes.But didn't rule out the possibility of the presence of invisible compounds.During the evaluation, they noted that, while using the machine, my ahi rating was 8.3, well above the recommended rating of 5.I am not currently using the machine.In hopes of receiving another replacement, i contacted philips via their recall customer-service phone line but was rejected.Similarly, (b)(6) won't replace the machine until my current term of use ends in (b)(6).

• Brand Name: RESPIRONICS DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 18810506
• MDR Text Key: 336697303
• Report Number: MW5152171
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 0060695902733
• UDI-Public: (01)0060695902733
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX620H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White