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

Device Problems Disconnection (1171); Product Quality Problem (1506); Material Too Rigid or Stiff (1544); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

I received a replacement dreamstation2 recently.I used it briefly until my resmed unit was delivered.During this time the heated tube (smaller diameter) that came with the machine disconnected from the base of the coupler that attaches to the mask intake.It gradually worked less.I don't know if this is by design.I've been using cpap <10 yrs and never had the coupling separate in this location.I suffered no injury.Just picked up the loose end in the middle of night and reattached.My concern is for anyone who absolutely need a proper functioning tube.It is curious also that the coupling that attaches to the mask intake is so tight that i had to struggle to remove it when i switched machines.I'm glad i no longer have to deal with the phillips saga.Don't want to be bothered about it.If you are interested check it out on your end.

• Brand Name: DREAMSTATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS / RESPIRONICS INC.
• MDR Report Key: 16683895
• MDR Text Key: 312936335
• Report Number: MW5116345
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White