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

Patient Problems Aspiration/Inhalation (1725); Dyspnea (1816); Skin Inflammation/ Irritation (4545)

Event Date 09/20/2023

Event Type  Injury  

Event Description

Reporter stated her original device has been recalled in 2019 and the manufacturer sent her a replacement.Unfortunately, the replacement device was defective.She said it was blowing sand like white dust.She was told by the manufacturer not to use it.Philips contacted her to ship the device back to them.She said it took about two months and she did not have any machine to use until she received the 3rd device in june.After she received the third device, she was using it for a while without any problem.She was told by philips to turn off the device for some sort of compliance.She said when she turned it back on, the machine got hot.Her pulmonologist increased the pressure hoping it will fix the problem.8 days later the filter turn black.It was also had a funny odor.As a result her nasal passage got irritated.She changed the filter, then she was having difficulty to breath.She said it was next to impossible to exhale, as if something is blocking the device.Ref report: mw5149274, mw5149276.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 18334584
• MDR Text Key: 330855648
• Report Number: MW5149275
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic