MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS SYSTEM 1 BIPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cancer (3262); Unspecified Respiratory Problem (4464)

Event Date 08/01/2018

Event Type  Injury  

Event Description

Diagnosed with colon cancer (b)(6) 2018, had colon removed (b)(6) 2018 so no longer has colon cancer.Started philips respironics system 1 bipap machine in 2015 and developed cancer in (b)(6) 2018.Currently has spots on lungs.

• Brand Name: PHILIPS RESPIRONICS SYSTEM 1 BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13289603
• MDR Text Key: 284147764
• Report Number: MW5106742
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/18/2022

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
• Device Expiration Date: 01/01/2020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2022
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL ; FISH OIL ; LEVOTHYROXINE ; METOPROLOL ; VITAMIN B ; WARFARIN
• Patient Outcome(s): Other; Disability; Hospitalization; Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White