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

Patient Problems Fatigue (1849); Headache (1880); Depression (2361); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

I have had severe headaches and fatigue.I have had many tests and exams and they cannot diagnose the problem.I just recently had a narcolepsy test and it was negative.This has affected my life in tremendous ways.I fall asleep when just sitting and watching tv.I don't feel like going anywhere and has caused depression.I can supply test results if need at a later date if requested.

• Brand Name: PHILIPS/RESPIRONICS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18365696
• MDR Text Key: 331085707
• Report Number: MW5149415
• 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: Unknown
• Type of Report: Initial
• Report Date: 12/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BUPROPION.; COQ10.; ESCITALOPRAM.; ESTROVEN.; LEVOTHYROXINE.; MAGNESIUM.; METFORMIN.; MODAFINIL.; MULTIVITAMIN.; OMEPRAZOLE.; PROBIOTIC.; RIZATRIPTAN.; VITAMIN C.; VITAMIN D.
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White