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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Pain (1994); Increased Sensitivity (4538); Skin Inflammation/ Irritation (4545)

Event Date 10/12/2020

Event Type  Injury  

Event Description

I developed nasal passage sores and a cyst located under my left nostril that would not heal.A facial plastic surgeon surgically removed the cyst on (b)(6) 2021.I now have a scar under my nose.The painful nasal passage sores healed up when i ceased using the dreamstation cpap following the surgery.This correlation indicated to me that the cpap was causing my medical issues.Though i have not used the device for over four months, i continue to have sensitivity and irritation under my nose.Dr.(b)(6) (facial plastic surgeon) submitted a biopsy of my facial cyst (located just under my left nostril) to check for cancer.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12814253
• MDR Text Key: 280867221
• Report Number: MW5105308
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• 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: IMURAN; REMICADE
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White