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

Device Problem Nonstandard Device (1420)

Patient Problems Red Eye(s) (2038); Unspecified Respiratory Problem (4464)

Event Date 06/01/2021

Event Type  Injury  

Event Description

I had been using two philips cpap devices until being informed of the recall.During the time when i used the devices, i had red eyes and symptoms of irritated airways without knowing that was caused by the devices.Reference report: mw5118199.

• Brand Name: SYSTEM ONE CPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17078236
• MDR Text Key: 316778321
• Report Number: MW5118198
• Device Sequence Number: 1
• Product Code: MNS
• 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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian