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

Device Problem Insufficient Information (3190)

Patient Problem Cancer (3262)

Event Date 10/02/2021

Event Type  Death  

Event Description

Developed pancreatic cancer while using machine and passed away.

• Brand Name: DREAM STATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12960428
• MDR Text Key: 281984896
• Report Number: MW5105891
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White