MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS, INC. DREAMSTATION 2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2022

Event Type  malfunction  

Event Description

I have a recalled cpap from philips respironics (dreamstation) and received my "replacement" on (b)(6) 2022.I am reporting that philips is not providing an equivalent model.The dreamstation 2 i received is of very poor design.The water tank which needs to be cleaned and refilled daily is very difficult to access without spillage.It is also not compatible with my soclean device.When i called philips, all they said is that i can buy a new dreamstation if i don't like the dreamstation 2.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 14513951
• MDR Text Key: 292962551
• Report Number: MW5109924
• Device Sequence Number: 2
• 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: 05/23/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White