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

Model Number	FRX521H14C
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Angina (1710); Cough (4457)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the dream station 2.The manufacturer received information alleging particles in circuit and mask.Medical intervention was not specified.The patient alleges a cough and feeling as if she has angina.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously in reference to the dream station 2.The manufacturer received information alleging particles in circuit and mask.Medical intervention was not specified.The patient alleges a cough and feeling as if she has angina.A device was returned to a third-party service center.During the evaluation of the device at the third-party service center, the device was visually inspected and found the iso port, blower, blower outlet seal, inlet/outlet seal and heat plate were contaminated with limescale.Pollen filter needs to be replaced due to preventive maintenance.The faulty components of the reported unit were scrapped.The previously submitted report was submitted as a serious injury.Upon reassessment on 04-mar-2026, it was updated to a product problem.Updated: evaluation method grid evaluation results code conclusion code grid.

• Brand Name: DREAMSTATION 2
• 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: 21375155
• Report Number: 2518422-2025-101882
• Device Sequence Number: 8550287
• Product Code: BZD
• UDI-Device Identifier: 00606959062757
• UDI-Public: 00606959062757
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FRX521H14C
• Device Catalogue Number: FRX521H14C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown