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

Device Problems Nonstandard Device (1420); Output Problem (3005)

Patient Problem Dyspnea (1816)

Event Date 06/15/2021

Event Type  Injury  

Event Description

Shortness of breath; i have been using my philips dreamstation for about 4 years.In the last 6 months, i have been noticing that i wake up gasping for air and a horrible taste in my mouth.My humidifier tray is filled with slime that has to be cleaned out every day.I wake up feeling like i didn't sleep well.I went online to see if i could find anyone else with these issues and found the recall notice.I went to pulmonologist and was sent for a chest xray and a pulmonary function test.I was able to get a resmed device as a replacement and my sleep and breathing have been making good improvements back towards normal.Philips has had no communication with me since i recorded my device as a recall eligible.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12331588
• MDR Text Key: 267076694
• Report Number: MW5103279
• Device Sequence Number: 1
• Product Code: BZD
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 59 YR
• Patient Weight: 118