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

Model Number SN J19401450B6A5

Device Problems Particulates (1451); Patient Device Interaction Problem (4001)

Patient Problems Dry Eye(s) (1814); Visual Disturbances (2140)

Event Date 11/01/2021

Event Type  Injury  

Event Description

My eyes have been extremely dry.I have followed the self-care routines recommended by my ophthalmologist with little improvement.My eyes are so dry that my vision becomes affected.While i have a history of chronic dry eye symptoms, i have always been able to self-treat and get relief.Currently, the symptoms are not abating.Could this be exacerbated by particles in my cpap machine? fda safety report id# (b)(4).

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12860962
• MDR Text Key: 281208609
• Report Number: MW5105509
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SN J19401450B6A5
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2021
• Patient Sequence Number: 1
• Treatment: ADVIL; BIO TEARS ; FLUVOXAMINE; LIFE FORCE MULTI VITAMIN; LORAZEPAM; MONTELUKAST ; OMEPRAZOLE; VITAMIN C; ZIOPLAN
• Patient Outcome(s): Disability
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White