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

Device Problem Unintended Collision (1429)

Patient Problems Hyperglycemia (1905); Sleep Dysfunction (2517); Weight Changes (2607)

Event Date 06/28/2022

Event Type  malfunction  

Event Description

A (b)(6) is my claim number with phillips regarding the recall of my cpap machine.I'm not able to use it and they have not replaced it.I'm worried i am going to have a stroke.I either want it replaced or want a refund to buy a new machine.I've gained weight and my blood pressure is up due to lack of sleep for almost a year now.Fda safety report id # (b)(4).

• Brand Name: DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS / RESPIRONICS INC.
• MDR Report Key: 14874634
• MDR Text Key: 295150986
• Report Number: MW5110617
• 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: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White