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

Model Number	CAX1130T12C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.A dreamst bipap device was returned to a third-party service center with no initial alleged complaint.During the evaluation of the device, the service technician observed visible foam degradation.Additionally, the third-party service technician found error codes e223 (err_low_pressure_regulation) and e226 (err_sensor_press_unreliable).The device was scrapped by the service center after the evaluation was completed.At this time, no further investigation can be performed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: DREAMSTATION BIPAP AVAPS
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 23311334
• Report Number: 2518422-2025-111052
• Device Sequence Number: 20290294
• Product Code: MNS
• UDI-Device Identifier: 00606959425552
• UDI-Public: (01)00606959425552
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102465
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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: CAX1130T12C
• Device Catalogue Number: CAX1130T12C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2018
• 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