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

Patient Problems Asthma (1726); Sleep Dysfunction (2517); Cough (4457)

Event Type  Injury  

Event Description

Recall on dreamstation.Patient's wife called and stated he is having symptoms such as chronic coughing, sinus problems, insomnia, and he has been diagnosed with asthma.Patient has stopped using machine.

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS INC.
• MDR Report Key: 18650676
• MDR Text Key: 334745516
• Report Number: MW5151085
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Sex: Male