MAUDE Adverse Event Report: PHILLIPS RESPIRONICS / RESPIRONICS, INC. DREAM STATION 2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Patient Problems Apnea (1720); Arrhythmia (1721); Asthma (1726); Dyspnea (1816); Inflammation (1932); Nausea (1970); Pain (1994); Dizziness (2194); Low Oxygen Saturation (2477); Sleep Dysfunction (2517)

Event Date 03/06/2024

Event Type  Injury  

Event Description

I use the dream station 2 for cpap therapy and on (b)(6) 2024 i started smelling an electrical burning smell through my cpap.I of course reported it to my medical supply company (b)(4) and also my pulmonologist dr (b)(6) with (b)(6).In the days proceeding, i have had lung inflammation, accompanied with pain, nausea, sleeping issues with more apnea events, and oxygen drops.It was suggested that the machine be turned in for repair or replacement.(b)(4) told me they were aware of thermal issues with this device and would suggest my doctor writing a new prescription for a res-med machine.This was the third similar incident using this device that has occurred since i've been a user of the dream station 2.In (b)(6) of 2023, 7 1/2 months prior to (b)(6) 2024, there was a much stronger burning smell or burning electrical smell followed by multiple trips to my doctor, multiple calls, and 3 emergency room visits in regards to multiple serious respiratory issues such as lung inflammation, pain, nausea, low oxygen levels, dizziness, and heart palpitations.My oxygen levels were greatly effected and i was placed on an oxygenator.The dream station 2 was replaced by my medical device supplier (b)(4) for the same above listed issue.Upon surrendering the device for replacement a charred like black substance was discovered falling out of the machine.The machine was still under warranty and was replaced.(this was the second incident.) the first incident occurred in (b)(6) 2022 with the same scenario/ incidents happening, the smell of electrical burning through the machine occurred while using followed by breathing issues, asthma attacks, lung inflammation, multiple doctor visits and er visits as well as being admitted for breathing issues.These 3 incidents occurred after 7-8 months of regular 8-9 hours of cpap therapy a night and cleaning and caring for the machine as instructed.This is not safe for use after 7 months the machine has overheating issues and causes damage to the user please investigate and deal this product unsafe for use it is dangerous.I can supply more information or details if needed please call or email.(b)(6) thank you.Reference report: mw5152992.

• Brand Name: DREAM STATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 18940564
• MDR Text Key: 338261494
• Report Number: MW5152991
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTEROL.; ALEVE.; CETIRIZINE.; IBUPROFEN.; MONTELUKAST.; MUCINEX.; ONE A DAY MULTIVITAMIN.; TRELEGY.; VITAMIN B12 SUPPLEMENTS.; VITAMIN D.; VITAMIN K.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White