MAUDE Adverse Event Report: PHILLIPS RESPIRONICS / RESPIRONICS, INC. SYSTEMONE ASV4; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Patient Problems Abdominal Pain (1685); Cancer (3262)

Event Date 10/17/2021

Event Type  Injury  

Event Description

Kidney mass (left kidney ) detected while in emergency room (er) for abdominal pain; diagnostics indicated probable cancer, left kidney removed (b)(6) 2021.Pathology identified non clear cell renal carcinoma with rhabdoid features stage 1b.Through (b)(6) 2023 no metastasis or recurrence detected.

• Brand Name: SYSTEMONE ASV4
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILLIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 17870460
• MDR Text Key: 325014772
• Report Number: MW5146518
• 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: 09/28/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2023
• Patient Sequence Number: 1
• Treatment: ALLERGY; BLOOD PRESSURE; CENTRUM; FISH OIL; GOUT MEDICATION; VITAMINS
• Patient Outcome(s): Disability; Life Threatening; Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White