MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Use of Device Problem (1670)

Patient Problems Cancer (3262); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/10/2020

Event Type  Injury  

Event Description

I began usage of the philips respironics medical device system one from 2012 to 2017.I was prescribed the medical device by yale sleep medicine by (b)(6), md.Usage was 4 hrs per day.During this duration, i experienced new and worsening medical conditions which could be presumptive conditions to pfas exposure.Glycemic dysfunction hyperglycemia insulin dysregulation diabetes type 2 hyperlipoidemia - worsening cholesterol during this time duration.Increased risk of testicular cancer.Testicular cancer, reproductive cancer recurrent internal, diseased para-aortic lymph node, yolk sac sarcoma - 2020.These conditions are well documented in medical records from 2012- 2023.

• Brand Name: SYSTEM ONE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17079460
• MDR Text Key: 316775812
• Report Number: MW5118220
• 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: 06/02/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Patient Sequence Number: 1
• Treatment: ASPIRIN ; D3; FARXIGA; FENOFILBRATE ; FISH OIL ; HUMALOG; LANTUS; LISINOPRIL ; MULTI-VITAMIN; ROSUVASTATIN ; SODIUM BICARBONATE; TUMERIC
• Patient Outcome(s): Other; Hospitalization; Life Threatening; Disability
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White