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

Model Number DSX520H11C

Device Problems Particulates (1451); Decrease in Pressure (1490); Filtration Problem (2941)

Patient Problems Aspiration/Inhalation (1725); Fatigue (1849); Headache (1880); Sore Throat (2396); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 02/04/2023

Event Type  Injury  

Event Description

Philip dreamstation cpap that was the replacement for the recalled one had fine white powder clogging up the replaceable filter in the machine.This made it not work right with noticeable less air pressure and breathing in the white powder.Had sleep problems, increased sleep apnea symptoms, headache fatigue, foggy thinking, daytime sleepiness, sore throat, etc.Happened twice with different filters so is an ongoing issue.Will stop using cpap now.Very concerning since i breathed it in for months.

• Brand Name: DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16437527
• MDR Text Key: 310318514
• Report Number: MW5115170
• 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: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White