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

Model Number	FRX521H14C
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A device was returned to a third-party service center for service.There was no report of serious patient harm or injury.There was no report of medical intervention.Customer complaint the machine turns off and on was confirmed.During the evaluation of the device, they found pca is burnt, humidifier water tank is contaminated, iso port and inlet/outlet seal are contaminated, heat plate and blower are not functional, pollen filter needs replacement due to preventive maintenance.Device return to pil.
Additional Manufacturer Narrative
The device was returned to the product investigation lab for further evaluation.During the evaluation of the device, pca burnt was found.Humidifier water tank is contaminated, iso port and inlet/outlet seal are contaminated, heat plate and blower are not functional, pollen filter needs replacement due to preventive maintenance.After investigation, customer requested device scrapped.

• 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: 22750723
• Report Number: 2518422-2025-108865
• Device Sequence Number: 13179840
• Product Code: BZD
• UDI-Device Identifier: 00606959062757
• UDI-Public: (01)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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• 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: FRX521H14C
• Device Catalogue Number: FRX521H14C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/22/2025; 04/22/2026
• Date Device Manufactured: 07/05/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown