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	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information in regard to a dreamstation 2 advanced auto cpap device.The patient alleges that during an annual visit, the technician saw that one side of the medical device had melted.In addition, the patient does not use the built-in humidifier and it was noted that the humidifier was set to 5.There was no report of patient harm or injury.No medical intervention was required.The device was returned to the manufacturer on april 11th, 2023, and is awaiting evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
As per device evaluation received on 04/04/2024: the ds2adv auto cpap was returned to the manufacturer for investigation.Using the power supply and power cord that were returned with the device, and a known good, heated tube, manufacturer confirmed that the device powers on, provides airflow, the heated tube heats, and the heater plate heats.During the investigation, the manufacturer observed a white unknown dust contaminant on the water tank and water tank seal.An unknown dust contaminant was observed on the ui panel and top enclosure.The center enclosure exterior was observed to have a melted appearance to the side of it, likely due to a source external to the device.An unknown dust contaminant was also observed on the inlet of the blower box, blower, blower seal, blower box, and bottom enclosure, confirming debris in the airpath.The manufacturer confirmed that the device enclosure had a melted spot on the center enclosure, likely due to an outside source and could not confirm a thermal event to the device.Additionally, the device was scrapped.In this report, box d, h has been updated/corrected.

• 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 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18318018
• Report Number: 2518422-2023-35123
• Device Sequence Number: 6115587
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: FRX521H14C
• Device Catalogue Number: FRX521H14C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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