MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 1; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION 1

Device Problem Product Quality Problem (1506)

Patient Problem Anxiety (2328)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

Philips respironics inc sent me a refurbished device as part of the recall of my dreamstation machine.I am suffering from anxiety using this device as it's refurbished.I don't know what's new? where it's been used? whose had it? how long it will last? i am concerned over the hygiene and how clean the machine is.I would like a brand new device for piece of mind.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION 1
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 15550487
• MDR Text Key: 301361046
• Report Number: MW5112455
• 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: 10/03/2022

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 Model Number: DREAMSTATION 1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2022
• Patient Sequence Number: 1
• Treatment: BENICAR METOPROLOL ; CRESTOR; ZOLOFT
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 163 KG
• Patient Race: White