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

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

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Event Description

I was using my phillips dreamstation cpap machine and was awakened by an intense and horrible smell coming from the machine i was inhaling.It was intense enough to wake me up.Even though i immediately took it off, the smell permeated me for most of the day in my nostrils and in my mouth.I stopped using it completely when this happened which was about (b)(6).I then called my sleep apnea doctor last week about the problem and asked how to get a new machine saying i didn't really want to get the same brand after my experience which i told her about.It was then she asked: you have a phillips dream machine? it was then i learned of the recall and the need to register, which i did today.Up until then, i knew nothing about the recall and hadn't received any notification from anyone, not from the doctor who prescribed a machine for me, not from the medical supply vendor i purchased it from nor from the manufacturer, phillips.They sound as if they haven't had many complaints and they indicate they're great at making sure their machines are safe.Yet here we are.How do i learn what i've inhaled? are you researching this to provide the public with the complete information? fda safety report id # (b)(4).

• Brand Name: PHILLIPS DREAM MACHINE, SLEEP APNEA MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12245441
• MDR Text Key: 264349808
• Report Number: MW5102837
• Device Sequence Number: 1
• Product Code: BZD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

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: 07/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 75