MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. PHILIPS RESPIRONICS DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DREAMST AUTOSV

Device Problem Particulates (1451)

Patient Problems Dyspnea (1816); Headache (1880)

Event Date 06/19/2023

Event Type  Injury  

Event Description

I have a philips respironics dreamstation bipap autosv.Serial (b)(6).This device was recalled on june, 2021.I immediately registered my device with the philips respironics recall and it was confirmed with confirmation (b)(6).I haven't received a new device.I was told by my medical doctor that as long as i didn't have any black particles in my machine, i needed to continue using it because of my central sleep apnea and my obstructive sleep apnea.On (b)(6) 2023, i had black particles under my mask on my face.I discontinued the device on the night of (b)(6) 2023.I now wake up gasping for air and my blood pressure is not controllable.I also wake up with headaches.I have called the respironics recall number 977-907-7508.They cannot give me a date when i will receive a new device.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 17229937
• MDR Text Key: 318242912
• Report Number: MW5118988
• 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: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMST AUTOSV
• Device Catalogue Number: DSXH11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADDERALL 20MG TWICE A DAY.; AMLODIPINE 5MG EVERY DAY.; ATENOLOL 50MG TWICE A DAY.; CALCIUM/MAGNESIUM.; CLONAZEPAM 0.5MG EVERY DAY.; CLOPIDOGREL 75MG EVERY DAY.; D3.; ESCITALOPRAM 20MG QD EVERY DAY.; LEVOTHYROXINE 100MCG EVERY DAY. ; MULTIVITAMIN.; OMEGA 3.; PROBIOTICS.; ROSUVASTATIN 5MG EVERY DAY.; TRAZODONE 150MG EVERY DAY.; UBIQUINOL.; VIT D3; VIT. C.
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White