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	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The device was received and evaluated by the manufacturer¿s product investigation lab (pil).The 15mm heated tube returned in an opened shipping packaging and could observe a damaged coil wire (plastic on wire looking as if it was melted).The plastic tubing was not damaged.Pil could determine the rest of the tubing was damage and defect free and still in a normal design orientation as intended.Pil confirmed the complaint of ¿broken/pierced/exposed heating wires¿ and could not determine the cause for the complaint.Pil could conclude that based on the cause determination for the complaint, no further corrective action is required for this complaint.No further investigation is needed.The 15mm heated tube has been scrapped per the requirements set forth in work instruction 8.4-1131 revision 10 and disposed of accordingly.No further investigation will be performed.

• Brand Name: DREAMSTATION
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24956441
• Report Number: 2518422-2026-011123
• Device Sequence Number: 18605236
• Product Code: BZD
• UDI-Device Identifier: 00606959022331
• UDI-Public: (01)00606959022331(10)10883059
• 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: Other,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 04/22/2026
• 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