MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. DREAMSTATION 2 CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number HH1551/01

Device Problems Structural Problem (2506); Contamination /Decontamination Problem (2895); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Unspecified Respiratory Problem (4464)

Event Date 06/06/2023

Event Type  Injury  

Event Description

I have a philips dreamstation 2 that i believe has a design defect with the humidity chamber.Specifically, to refill the humidity chamber (and unlike the dreamstation 1 which has a spring and no removable lid) you have to remove the lid from the humidity chamber to refill it.As there is no where to hold on to it, you are constantly touching the inside top of the humidity chamber which adds the bacteria from your hands to what should be a sterile environment.Previously, i had never had issues with the dreamstation 1 (because of the lid that uses a spring and never comes detached, you don't have to touch the inside of the humidity chamber), but now i get sinus infections every month since receiving my replacement device.I am not sure if my description makes sense, but if you have the dreamstation 1 and dreamstation 2 and try to fill the humidity chambers, you will notice the defect and the fact that you are frequently touching the inside of the humidity chamber every time you take the lid off to fill it.I clean my device regularly, but unfortunately i add bacteria to the tank every night as you have to completely remove the lid to fill it and there is no where to really grab it.I have compared this to my dad's resmed and my uncle's device, and none of them have this.I think this was an oversight that keeps giving me sinus infections.

• Brand Name: DREAMSTATION 2 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 17086352
• MDR Text Key: 316858827
• Report Number: MW5118266
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HH1551/01
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DEXCOM CGM(CONTINUOUS GLUCOSE MONITORING.); HUMALOG INSULIN; T CONNECT INSULIN PUMP
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White