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

Model Number DREAMSTATION

Device Problems Break (1069); Degraded (1153); Nonstandard Device (1420); Chemical Problem (2893); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Burning Sensation (2146)

Event Date 06/14/2021

Event Type  Injury  

Event Description

Admitted carcinogenic effect; i used the philips respironics dreamstation for the past 4 years and most they have come out with a recall regarding their foam breakdown and off-gassing of carcinogenic chemicals (foam is actually in the airway path).Prior to this recall, in the past 3 months i have begun to experience chest pain and burning sensations after using this product-most notable upon waking and then waning over the course of the day.Respironics claim the fda is not mandating a recall.I would like to know why there is not a mandated recall with a manufacturer's admitted known carcinogenic effects in a product designed to improve health.They claim a low rate of incidence-that is probably because no one in their right mind would think to associate these negative effects with a device designed to improve their health.Only after they created a recall did i put two and two together.It is unconscionable to not mandate a recall where the manufacturer is saying do not use any further.I demand to know what action is being taken with regards to allowing this occur.How was this product even approved? foam will breakdown.What was the manufacturer's claimed lifespan of the foam? what was the known chemical composition of the foam and why did the fda approve it? i am going to hire a lawyer and seek this information as i believe the fda is also liable.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ / RESPIRONICS INC
• MDR Report Key: 12058799
• MDR Text Key: 258706543
• Report Number: MW5102113
• Device Sequence Number: 1
• Product Code: BZD
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 93