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

Model Number	BLX520H15C
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was sent to a third-party service center for investigation.During evaluation, the third-party service center found burned pca.Due to the alleged malfunction, the device will be forwarded to the manufacturer¿s product investigation lab (pil) for additional testing and investigation.A final report will be sent once the investigation is concluded.
Event or Problem Description
The manufacturer received information alleging a chip was blown on pcb occurred on a ds2 adv auto cpap.The device was not in use on a patient at the time of the occurrence.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.

• Brand Name: DREAMSTATION 2 ADVANCE AUTO CPAP
• 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: 24233814
• Report Number: 2518422-2026-003726
• Device Sequence Number: 18385195
• Product Code: BZD
• UDI-Device Identifier: 00606959062818
• UDI-Public: (01)00606959062818
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K200480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: BLX520H15C
• Device Catalogue Number: BLX520H15C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown