MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADVANCED 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	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A dreamstation 2 advanced auto cpap was returned to the third-party service center for a repair.During the evaluation it was noted that the device's printed circuit assembly is burnt.The investigation is ongoing.The device will be forwarded to the manufacturer for further investigation.
Additional Manufacturer Narrative
A dreamstation 2 advanced auto cpap was returned to the third-party service center for a repair.During the evaluation it was noted that the device's printed circuit assembly is burnt.The investigation is ongoing.The device will be forwarded to the manufacturer for further investigation.The previous report b5 was incomplete.A dreamstation 2 advanced auto cpap was returned to the third-party service center for a repair.During the evaluation it was noted that the device's printed circuit assembly is burnt, iso port is contaminated, heater plate is contaminated/corroded, ui panel flex cable is burned due to the printed circuit assembly, motor blower is contaminated, and some screws are corroded.The pollen filter was replaced for preventative maintenance.In conclusion, the device's printed circuit assembly and new screw kit need to be replaced.The investigation is ongoing.The device will be forwarded to the manufacturer service center for further investigation.If any additional information is received, a follow-up report will be filed.

• Brand Name: DREAMSTATION 2 ADVANCED 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: 23759545
• Report Number: 2518422-2025-112397
• Device Sequence Number: 10075760
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: Other
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown