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

Device Problem Use of Device Problem (1670)

Patient Problem Cancer (3262)

Event Date 12/08/2021

Event Type  Death  

Event Description

Started using philips cpap dreamstation on (b)(6) 2021.Diagnosed with stage 4 lung cancer on (b)(6) 2021.Testing all done between (b)(6) 2021 through her death in (b)(6) 2022.

• Brand Name: PHILIPS CPAP DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17135807
• MDR Text Key: 317306158
• Report Number: MW5118405
• 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: 06/12/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2023
• Patient Sequence Number: 1
• Treatment: AMITRIPTYLINE ; ATORZASTATIN ; METFORMIN ; PANTOPARZOLE; VITAMIN C; ZINC
• Patient Outcome(s): Life Threatening; Death; Required Intervention; Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White