MAUDE Adverse Event Report: PHILIPS / RESPIRONICS DREAMSTATION GO PORTABLE AUTO CPAP SYSTEM WITH HEATED HUMIDIFIER AND DREAMWEAR F; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSG500S11

Device Problems Nonstandard Device (1420); Defective Device (2588); Patient-Device Incompatibility (2682); Device Contamination with Chemical or Other Material (2944)

Patient Problems Discomfort (2330); Sore Throat (2396); Sleep Dysfunction (2517)

Event Date 06/18/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, i purchased for over (b)(6) and began using a dreamstation go auto-adjusting cpap machine for severe sleep apnea diagnosed a few days earlier.From the beginning of use, i woke up with a runny nose, congestion, sore throat, and a feeling of discomfort in my lungs that felt as if my lungs were raw.After being awake an hour or two, the symptoms resolved, so i knew i did not have a cold.Since i had never used a cpap before, i thought these symptoms were due to being unused to cpap treatment.On (b)(6) 2021, i found a small bit of black debris in my mask.On (b)(6) 2021, i received word that phillips respironics had recalled my dreamstation go because the pepur sound abatement foam released harmful gases and could decompose under normal use, allowing debris in the air path.I stopped using it immediately.A few days later, i purchased an auto-adjusting cpap by another company.Since then, i have experienced none of the previous symptoms.The runny nose, congestion, sore throat, and lung discomfort i had experienced for over two months was completely gone.I believe those symptoms were caused by the foam in the dreamstation go.I have registered my dreamstation go in philips respironics' recall, but have received no further communication with them.I believe this voluntary recall should be turned into a mandatory one and that philips respironics should be required to refund the cost of the machines and accessories which will only work with those machines.I have a product less than three months old, which is dangerous to use, along with a humidifier and travel case that will only work with this machine.Philips respironics has given us no indication of when they will take care of this, forcing me to purchase a new machine to protect my health.I am also concerned because of the stated risk of cancer due to exposure to this pe-pur foam.I have a family history of cancer and would have never exposed myself to this risk willingly.Please make philips respironics do what is right and pay us back for what we've wasted because of them and set aside funds to treat any conditions that come out of this.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION GO PORTABLE AUTO CPAP SYSTEM WITH HEATED HUMIDIFIER AND DREAMWEAR F
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS
• MDR Report Key: 12137169
• MDR Text Key: 260776729
• Report Number: MW5102371
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959044463
• UDI-Public: (01)00606959044463
• 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: 07/05/2021

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
• Device Model Number: DSG500S11
• Device Catalogue Number: DSG500S11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 134