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

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2023

Event Type  malfunction  

Event Description

My dreamstation two intermittently starts at a pressure it is not set at.It's set 7.5-9.5, ramp off.But at least once a week it starts at 10.Unsure why.I turn it off and back on again and then it will start at 7.5 again.

• Brand Name: DREAMSTATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 16771244
• MDR Text Key: 313685755
• Report Number: MW5116844
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female