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

Device Problems Nonstandard Device (1420); Contamination /Decontamination Problem (2895); Patient Device Interaction Problem (4001)

Patient Problem Cancer (3262)

Event Type  Injury  

Event Description

Hello, i received a replacement philips respironics dream station machine about a month ago and when i was refilling the water chamber, i noticed oily spots floating in it with small pieces of the black foam in them.I received the exact same model instead of the upgraded model (white machine).When my old machine was replaced due to being recalled, it did the exact same thing.This leads me to believe that they did nothing to repair the machine and only replaced it with a new one.It seems that they are pulling the wool over the fda's eyes to save money.I contracted bladder cancer which is one of the things that the recalled machine's cause and i'm afraid to continue using the machine as it may cause the cancer to return after my prior surgery.Please contact me asap by email or phone to discuss the problem.

• Brand Name: DREAMSTATION MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 13117963
• MDR Text Key: 283087775
• Report Number: MW5106356
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2021
• Patient Sequence Number: 1