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

Model Number DREAM STATION GO

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

Consumers expect firms to stand behind the products they produce and sell.Consumers expect that when there is a recall with a replacement that it is performed in a timely manner.Background: i purchased two dream station cpap machines.One is a dream station go (travel machine recall claim # (b)(4) and one a dream station 2 (home machine).Both were recalled and claims filed in june 17, 2021.Philips originally promised a one-year recall and replacement.During this recall, i have had to purchase a third machine from a different vendor for home use due to severe sleep apnea.Philips finally replaced the home machine.Yet, continues to delay replacement of travel machine, including blaming the fda for the holdups, continues to offer the dream station go machine on its home website and has refused to offer a refund for a product that was covered under warranty during the recall period.Copies of emails are available supporting this.We are resuming travel and need a travel machine.It's unrealistic to expect me to buy a fourth machine because of philips.What are the requirements and timelines for replacement of recalled items? and, what additional actions can be taken against philips for failure to resolve this problem in a timely manner? reference report: mw5116743.

• Brand Name: DREAM STATION GO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 16763007
• MDR Text Key: 313687269
• Report Number: MW5116742
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAM STATION GO
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2023
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE, ROSUVASTATIN, CARVEDILOL, TIMOLOL MALEATE.; VIT D (VITAMEN D).
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White