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	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information regarding a ds2 adv auto cpap device.The patient has alleged humidifier does not work.There was no report of patient harm or injury.The device was returned to a third-party service center.The technician found pca was burned during the device evaluation.Although there was no reported patient death or serious injury, this complaint is reportable because the reported issue/event could potentially cause or contribute to a death or serious injury if the malfunction were to recur.The faulty unit will be returned to the product investigation laboratory for further investigation.A follow up report will be submitted when the manufacture's investigation is complete.

• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 22712674
• Report Number: 2518422-2025-108680
• Device Sequence Number: 15856000
• Product Code: BZD
• UDI-Device Identifier: 00606959062818
• UDI-Public: (01)00606959062818
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• 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