MAUDE Adverse Event Report: RESPIRONICS, INC. DS2 ADV AUTO CPAP W/HUMID CELL/BT, BL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX520H15C
Medical Device Problem Codes	Circuit Failure (1089); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of a ds2adv auto cpap device was contacted in reference to a thermal product malfunction.The service center received information alleging pca burned.There is no allegation of patient harm or injury.No medical intervention was required by the patient.During the technician's repair, the technician noticed pca burned.Should additional relevant information become available, a follow-up report will be submitted.
Additional Manufacturer Narrative
The manufacturer previously reported information in reference to a thermal product malfunction of a ds2adv auto cpap device.The service center found evidence of a burned pca.The device is being transferred to the manufacturer for further investigation.The following sections were corrected: complete? and h6 codes.Previously complete? was answered as 'yes' but is now corrected to 'no' to reflect the ongoing investigation.Evaluation method code grid was corrected to 'type of investigation not yet determined.' evaluation results method code grid was corrected to 'results pending completion of investigation.' conclusion code grid was corrected to 'conclusion not yet available.'.

• Brand Name: DS2 ADV AUTO CPAP W/HUMID CELL/BT, BL
• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 22692948
• Report Number: 2518422-2025-108623
• Device Sequence Number: 9143273
• 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): 08/05/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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