MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. DREAMSTATION 1 AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Aspiration/Inhalation (1725); Headache (1880)

Event Date 12/30/2023

Event Type  Other  

Event Description

Hello.My phillips dreamstation cpap was part of the recall program.I registered my device, received a remanufactured one through the recall program, and used this machine until this past weekend.I have never used an ozone cleaner on either device, but i regularly washed the cleanable parts by hand with soap and water.The last week of december i had bad headaches for several mornings in a row; when i opened the cpap reservoir to check the water level, i noticed black spots around the tubing connector as well as the reservoir cover.This had never occurred before, and i have immediately stopped using this machine.I wanted you to know because the remanufactured cpap was supposed to be "safe." i hope i do not have longterm repercussions from using this machine, as i can't know how long it was emitting harmful fumes and/or particles.I am working with my insurance to get a new device.I can send photos if that would be helpful.Reference report: #mw5149875.

• Brand Name: DREAMSTATION 1 AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18463507
• MDR Text Key: 332670675
• Report Number: MW5149874
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: AMLODIPINE 5MG.; CALCIUM.; CPAP.; ESTRADIOL VAGINAL MCG.; MULTIVITAMIN.; VITAMIN C.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White