MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	FRX521H14C
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a thermal complaint on a dreamstation 2.The manufacturer received information alleging burning smell.There is no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
In the previous report, device name was given as "dreamstation 2" which is now corrected/updated to ds2adv auto cpap.Additionally, the udi number and manufacture date are corrected/updated in the report.
Additional Manufacturer Narrative
The ds2adv auto cpap device was returned to the third-party service center for evaluation, and the customer¿s complaint of a burning smell when in use was confirmed.During the evaluation it was noted that the device's heater plate was damaged, the inlet/outlet seal and iso port were contaminated, and the pollen filter needed replacing due to preventative maintenance.In conclusion, the device was not repaired but scrapped due the request of the customer.
Additional Manufacturer Narrative
This case was initially submitted as reportable.Following a detailed reassessment and alignment with the documented risk analysis, it has been concluded that the event does not meet the criteria for reportability under the applicable regulations.The risk severity associated with the occurrence of "burning smell, damaged heat plate and inlet/outlet seal and iso port are contaminated" is classified as low and does not present a serious risk to patient safety.

• Brand Name: DS2ADV 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: 21490611
• Report Number: 2518422-2025-102485
• Device Sequence Number: 20936013
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/16/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 06/24/2025; Not provided; Not provided
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 06/24/2025; 09/02/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2021
• 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