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

Model Number DSX500T11

Device Problems Contamination (1120); Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problems Red Eye(s) (2038); Sore Throat (2396)

Event Date 04/23/2021

Event Type  Injury  

Event Description

I was diagnosed with sleep apnea and have used the philips dreamstation noncontinuous ventilator at night (serial number (b)(4)) for the past 4 years.During the second year of use, i noticed black mold growing in the humidifier in an area that could not be cleaned because of the way the plastic overlaps.I complained to the company that provided the ventilator to me, (b)(6), and asked for a replacement humidifier.They advised that i pull the plastic apart and drip rubbing alcohol into that area.It seemed to work ok.I continued to use my bipap but have noticed throat irritation, and red eyes that i blamed on other health situations like tiredness and wearing an n95 during a pandemic.In (b)(6) 2021, i had an eye exam with my eye doctor.He expressed concern about the line of irritation that followed where my eyelids closed.He suggested i wear an eye mask to try to protect my eyes from the air discharge vent that blew on my eyes at night.This month i noticed a lot more mold growing in the humidifier.I am a nurse and so i clean almost all my bipap equipment daily and i worked hard to clean it again.I used vinegar, mild soap which seemed to help, however the mold quickly grew again.Today i received a recall notice for the bipap machine that i use and it all seemed to make sense.I'm writing to let you know that i was definitely affected and reported the mold problem soon after starting to use this machine, but did not get an adequate response from my vendor.I uploaded pictures of the ventilator and the mold that could not be removed through cleaning.Thank you for the work you are doing and i'm glad i found out about this site.Fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12474959
• MDR Text Key: 271696218
• Report Number: MW5103929
• 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: 09/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11
• 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): Disability
• Patient Age: 48 YR
• Patient Weight: 73