MAUDE Adverse Event Report: RESPIRONICS, INC. DS2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX520H15C
Medical Device Problem Codes	Contamination (1120); Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a thermal complaint on a ds2 adv auto cpap device.The manufacturer received information alleged of having smell of burning from the device.There is no allegation of patient harm or injury.Medical intervention was not specified by the patient.The device was returned to the third-party service center for further evaluation.The device was evaluated.During the evaluation, the third-party service center found heater plate, blower, and iso port is contaminated, pca and ui bezel is defective, inlet/outlet seal missing, pollen filter.The device was scrapped as per customer request.
Additional Manufacturer Narrative
The case was initially submitted as reportable, with an allegation that the device is producing a burning smell.Following the repair evaluation by a field service engineer from a third-party service center, it has been concluded that the observed events do not meet the criteria for reportability under the applicable regulations.The risk severity associated with the occurrence of ¿smell¿ is classified as low and does not present a serious risk to patient safety.

• Brand Name: DS2 ADV 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: 22403579
• Report Number: 2518422-2025-107094
• Device Sequence Number: 15871505
• Product Code: BZD
• UDI-Device Identifier: 00606959062818
• UDI-Public: (01)00606959062818
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: BLX520H15C
• Device Catalogue Number: BLX520H15C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2022
• 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