MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTO SV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DSX900H11
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The dreamstation bipap device was returned to a third-party service center as part of the uno recall process with no initial alleged complaint.During the evaluation of the device, it was visually inspected, and the engineer found evidence of visible foam degradation inside the blower kit and displayed error codes: 22 (err_motor_flux_magnitude,), error code: 226 (err_sensor_press_unreliable), error code: 94 (err_rtc_stopped,).The device was scrapped by the service center after the evaluation was completed.
Additional Manufacturer Narrative
The 510k number, product name and recall z number were updated.

• Brand Name: DREAMSTATION BIPAP AUTO SV
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23995145
• Report Number: 2518422-2025-113076
• Device Sequence Number: 21463371
• Product Code: MNS
• UDI-Device Identifier: 00606959424401
• UDI-Public: (01)00606959424401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: DSX900H11
• Device Catalogue Number: DSX900H11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown