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

Model Number DSX500H11

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Cancer (3262)

Event Date 04/04/2023

Event Type  Injury  

Event Description

Started having back pain last month and lead to imaging and mri's.Discovered i have stage 4 lung cancer that has metastasized to brain, spine, bones and lymphnodes, i have been receiving radiation and chemo this month at (b)(6).The type of cancer i have is very aggressive.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESONICS / RESPIRONICS, INC.
• MDR Report Key: 17052653
• MDR Text Key: 316502532
• Report Number: MW5118094
• Device Sequence Number: 1
• Product Code: BZD
• 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: 05/29/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11
• Device Catalogue Number: DSX500H11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Disability; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White