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

Patient Problems Aspiration/Inhalation (1725); Asthma (1726); Lymphoma (3263)

Event Type  Injury  

Event Description

After receiving the dreamstation 2 replacement cpap on 1/14/2020 for the 2 recalled devices i have from philips.Side note-i was diagnosed with cll(chronic lymphocytic leukemia), reactive airway disease in 2018 which i believe to be from the previous 2 recalled devices i used since 2012.I was noticing a burning smell blowing from the tube on occasion from the dreamstation 2.I stopped using it over safety concerns and went to a dental device for a while.Then asked my dr to prescribe a different brand.Did not put the puzzle pieces together until reading about the warning on dreamstation 2 cpap machines.Reference reports: mw5149220, mw5149222.

• Brand Name: PHILIPS DREAMSTATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 18324624
• MDR Text Key: 330822616
• Report Number: MW5149221
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White