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

Device Problems Particulates (1451); Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Cough (4457)

Event Date 06/11/2020

Event Type  Injury  

Event Description

Reporter calling, stating that she is having the same problems with her dreamstation 2, the replacement cpap machine for her original recalled dreamstation.She states "here we go again" regarding "black stuff" coming out of the tubes and hosing and "it gets all over my face." she states has "problems 24/7" with coughing and difficulty breathing.Reporter states that the antibacterial in-line filters between her mask and the machine get clogged with black material "every 10-15 days" and that she has gone through many of these filters because they repeatedly clog.Meanwhile, the filter in the dreamstation 2 machine is not dirty with the black material, nor clogged.Reporter feels her dreamstation 2 is having the "same exact problems" as her original dreamstation device.Reference reports: mw5115501, mw5115502.

• Brand Name: DREAMSTATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 16501597
• MDR Text Key: 310911918
• Report Number: MW5115500
• 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: 03/06/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female