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

Model Number	HT15
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging heated tubing.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
A dreamstation humidifier device was returned to a service center for evaluation.There was no report of serious or permanent harm or injury.There was no report of medical intervention.During the evaluation of the device no damage or defects were observed.Pil mated the tubing to a pil dreamstation and humidifier and then to a quick lung.The tubing connects to the humidifier securely and will not disconnect until the release tabs are engaged.Pil applied power and heard a swooshing air sound around the tubing connector/humidifier area.The tubing connector was more thoroughly looked at.Pil observed the gasket surrounding the tubing/connector connection was missing.The reported problem "tubing is leaking" could not determine the cause for the complaint.No further corrective action is required for this complaint.No further investigation is needed.No death, serious harm or injury was reported.Analysis of past events do not indicate an adverse event has occurred due to the reported allegation or would be likely to occur, if the product allegation was to recur.In addition, a review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.This event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or reportable product malfunction.

• Brand Name: DREAMSTATION
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 21901687
• Report Number: 2518422-2025-104621
• Device Sequence Number: 4059429
• Product Code: BZD
• UDI-Device Identifier: 00606959022331
• UDI-Public: (01)00606959022331
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: HT15
• Device Catalogue Number: HT15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown