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

Device Problem Nonstandard Device (1420)

Patient Problem Cancer (3262)

Event Date 03/01/2020

Event Type  Injury  

Event Description

Started using the recalled philips cpap in early 2020.Has a lung mass.Diagnosed with hepatocellular carcinoma of the liver.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 17228126
• MDR Text Key: 318289433
• Report Number: MW5118951
• 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: 06/23/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2023
• Patient Sequence Number: 1
• Treatment: BUDESONIDE.; IBUPROFEN.; TRAMADOL.
• Patient Outcome(s): Life Threatening; Hospitalization; Disability; Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White