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

Model Number DSX520T11C

Patient Problem Sleep Dysfunction (2517)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

My philips dreamstation 2 developed a very nasty smell in the water chamber that woke me in the middle of the night.In the morning the water chamber was empty, which was unusual after only 6 hours of use, and the nasty smell was still present in the empty chamber.I washed the chamber and mask thoroughly and the next night it again woke me with the smell after about 4 hours of use.I have discontinued the use of this machine.

• Brand Name: DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 18537045
• MDR Text Key: 333438556
• Report Number: MW5150503
• 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: Other
• Type of Report: Initial
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN 10 MG.; LANSOPRAZOLE 15 MG.; LEVOTHYROXIN 150 MCG.; LORATADINE 10 MG.; LOSARTAN 25 MG.; MULTIVITAMIN.; SERTRALINE 150 MG / DAY. ; TAMSULOSIN 0.4 MG.; VITAMIN E.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White