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

Model Number INTERTEK 3194661

Patient Problems Aspiration/Inhalation (1725); Dyspnea (1816)

Event Date 03/16/2024

Event Type  Injury  

Event Description

Philips respironics dreamstation 2 auto cpap advanced (b)(6), date (b)(6) 2021.From (b)(6) 2024 around 5 to 6 hours into each session it smelled like smoke through mask.Needed to remove the mask to breath.Had difficulty breathing for about 2 hours after.I contacted the philips device recall phone number 877-907-7508 and was told that the s/n was not on the recall list.They instructed me to call the medical device provider.I told them i already contacted the provider and they gave me the philips device recall phone number and the provider had said they could not help me with the device.I have stopped using the device since i have heart issues and cannot handle the breathing issues the device is causing.

• Brand Name: DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS - RESPIRONICS, INC/ RESPIRONICS, INC.
• MDR Report Key: 18949337
• MDR Text Key: 338348100
• Report Number: MW5153029
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INTERTEK 3194661
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMIODARONE 200MG; ENTRESTO 24-26; JANTOVEN 1MG & 1.25MG; METROPROLOL ; OMEPRAZOLE 20MG; PACEMAKER ; SUCCCINATE ER 50MG; TORSEMIDE 20MG; URINARY CONTROL SYSTEM
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White