MAUDE Adverse Event Report: PHILIPS ELECTRONICS LTD DREAMSTATION GO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Device Emits Odor (1425)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/05/2021

Event Type  Injury  

Event Description

I was using my dreamstation go because it was much newer than my dreamstation.Both were part of the recall, but my sleep doctor agreed the dreamstation go was the safer of the two machines.Noted a "burnt air" smell and regular bloody noses for a couple weeks (slowly getting worse).Switched to my partner's resmed and symptoms have improved.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION GO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS ELECTRONICS LTD
• MDR Report Key: 13237711
• MDR Text Key: 283781671
• Report Number: MW5106610
• 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: 01/09/2022
• 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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2022
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE; LISINOPRIL
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 150 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White