MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DSX700T11C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A dreamstation auto 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, the third-party service center visually inspected the device and found evidence of foam particles or degradation.The complaint was confirmed.The device had displayed error code e053 (err_comp_log_sem_timeout), e 130 (task_wdog_timeout) and e 200 (rtos_abort_err.There was no reported patient death or serious injury, however the reported issue/event is reportable due to the potential to cause or contribute to a serious injury as identified in capa pr7211, in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 23022428
• Report Number: 2518422-2025-109879
• Device Sequence Number: 18535191
• Product Code: BZD
• UDI-Device Identifier: 00606959025707
• UDI-Public: (01)00606959025707
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: DSX700T11C
• Device Catalogue Number: DSX700T11C
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2018
• 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-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown