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

Model Number	BLX520H15C
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a chip was blown on pcb occurred on a dreamstation 2 device.The device was not in use on a patient at the time of the occurrence.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.
Event or Problem Description
The ds2 adv auto cpap was returned to plexus third-party service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation, the service technician observed that the device component on pca was burned.The iso port also burn damage.Ui bezel is scratched and need to be replaced.The usb cover is missing and needs to be re-added.Pollen filter needs to be added for preventive maintenance the manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The device was assessed by a third-party service center.This report is being submitted to correct the b5 statement and update related fields.

• 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: 24153288
• Report Number: 2518422-2026-003127
• Device Sequence Number: 10059418
• Product Code: BZD
• UDI-Device Identifier: 00606959062818
• UDI-Public: (01)00606959062818
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: Other
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/20/2022
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• 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