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

Catalog Number DSX500H11C

Device Problem Insufficient Information (3190)

Patient Problems Cancer (3262); Solid Tumour (4552)

Event Date 06/15/2021

Event Type  Injury  

Event Description

I started feeling a nose irritation since late 2020 and reported it to my doctor.We tried different medications but it never completely succeeded.On (b)(6) 2021 i noticed a little growth on both sides of my neck and they have now grown to big tumors on both sides of my neck that have been diagnosed as undetermined carcinoma without a primary cancer source.Fda safety report id # (b)(4).

• Brand Name: RESPIRONICS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12446525
• MDR Text Key: 270915379
• Report Number: MW5103792
• 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: 09/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DSX500H11C
• 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): Hospitalization; Life Threatening; Other
• Patient Age: 51 YR
• Patient Weight: 77