MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC DREAM STATION AUTO CPAP HUMHTCELL DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500T 11C

Patient Problems Apnea (1720); Dyspnea (1816)

Event Date 06/20/2022

Event Type  Injury  

Event Description

I have sleep apnea.Unable to wear cpap(continuous positive airway pressure) due to device was suffocating me in my sleep.This is the reason why i've stopped wearing it.Tested positive for sleep apnea.Cpap required for sleep.

• Brand Name: DREAM STATION AUTO CPAP HUMHTCELL DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC
• MDR Report Key: 18704405
• MDR Text Key: 335461727
• Report Number: MW5151579
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2018
• Device Model Number: DSX500T 11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BD NEEDLES; CEPHALEXIN ; DICLOFENAC ; ESOMEPRAOLE ; FAMOTIDINE ; GABAPENTIN ; LAMOTRIGINE ; LIRGLUTIDE ; MENS VITAMINS; NALOXONE ; NORCO CYCLOBENZAPRINE ; OXYCODONE ; POLYETHYLENE GLYCOL ; PRAZOSIN ; QUETIAPINE; TYLENOL WITH HYDROCODONE
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native, White