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

Patient Problems Dyspnea (1816); Pain (1994); Unspecified Hepatic or Biliary Problem (4493)

Event Date 11/22/2023

Event Type  Injury  

Event Description

I have trouble breathing now and have pain in my liver.

• Brand Name: PHILIPS RESPIRONICS SYSTEM ONE Q SERIES
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 18238442
• MDR Text Key: 329467295
• Report Number: MW5148570
• 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: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: LISINOPRIL
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White