MAUDE Adverse Event Report: PHILIPS/ RESPIRONICS, INC. PHILIPS CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Insufficient Information (3190)

Patient Problem Lymphoma (3263)

Event Date 02/15/2019

Event Type  Injury  

Event Description

I was diagnosed with gastric lymphoma in (b)(6) 2019 and underwent radiation therapy.My oncologists periodically examine me for recurrence and will continue to do so.In (b)(6) 2021, i was diagnosed with mucosis fungeides which is a rare lymphoma of the circulatory system which effects the skin and i will meet with an expert in that field on (b)(6) to determine treatment.I am unaware of the likelihood of linking the cancer to the philips cpap machine, but i want the fda to be aware of the problem.Thanks.(b)(6).Fda safety report id # (b)(4).

• Brand Name: PHILIPS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS, INC.
• MDR Report Key: 12354065
• MDR Text Key: 267959305
• Report Number: MW5103408
• Device Sequence Number: 1
• Product Code: BZD
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 74 YR
• Patient Weight: 87