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

Patient Problem Aspiration/Inhalation (1725)

Event Date 05/15/2023

Event Type  Injury  

Event Description

After using this machine i kept smelling burnt smells from both of my dreamstation machines.I am not sure what to do.Reference report: mw5148653.

• Brand Name: DREAMSTATION 2 ADVANCE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18255378
• MDR Text Key: 329824057
• Report Number: MW5148654
• 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: 11/30/2023

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: 12/01/2023
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian