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

Model Number DSX520H11C

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Event Description

When water is used up from reservoir midway thru the night, they reservoir gets 100% dry and the continuous heat starts to make a horrific chemical smell.I smell it before when i left a non-stick pan on the electric oven.This is why i fear i could be inhaling formaldehyde or a toxic chemical.Philips never has any feedback area and i looked years ago when this first happened and even after this recall came out.Philips gives patients zero contact us or feedback to make them a aware.Current have dreamstation 2 i received after recall i have on 3 humidity.

• Brand Name: DREAMSTATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 18660787
• MDR Text Key: 334897364
• Report Number: MW5151133
• 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: 02/03/2024

1 Device was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX520H11C
• Was Device Available for Evaluation?: Yes