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

Model Number	FRX521H14C
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging dreamstation auto cpap screen does not switch on.The device was not known to be in use on a patient at the time of the occurrence.The dreamstation cpap device was returned to the manufacture's third-party service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that the device's pca and iso port was melted.Display ribbon cable was burnt.Additionally, the following parts were contaminated, inlet /outlet seal/isolator pollen filter needs replacing due to preventive maintenance.The root cause isn't confirmed at this time.The manufacturer's investigation is ongoing.If new additional information is received a follow-up report will be submitted.
Additional Manufacturer Narrative
The manufacturer previously reported that the manufacturer received information alleging dreamstation auto cpap screen does not switch on.The device was not known to be in use on a patient at the time of the occurrence.The dreamstation cpap device was returned to the manufacture's third-party service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that the device's pca and iso port was melted.Display ribbon cable was burnt.Additionally, the following parts were contaminated, inlet /outlet seal/isolator pollen filter needs replacing due to preventive maintenance.The root cause isn't confirmed at this time.This notification is being reviewed due to a user of ds2adv auto cpap device with allegations of does not switch on.The device was return to manufacturer product investigation laboratory (pil) for service.Pil was able to confirm the complaint, but not address the symptoms specified.A dust-like contaminant was observed on the ui display bezel, top enclosure, center enclosure, iso port, inlet/outlet seal, inside the inlet of the blower box, on the blower, blower seal, blower box, heater plate, heater plate spring, and bottom enclosure.It appeared to be possible burn marks from thermal damage were observed on the ui display bezel, ui ribbon cable, and iso port.

• 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: 23037614
• Report Number: 2518422-2025-109910
• Device Sequence Number: 9181727
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown