MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DSX1030T11C
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to a third-party service center for service.There was no harm or injury reported.During the evaluation of the device at the third-party service center, an err_sensor_press_unreliable error code was observed in the device's event log.There was no reported patient involvement.The recommended service is to replace the device's pca board to address the issue.No repair was performed.The device was dispositioned to be scrapped.No further investigation is warranted at this time.

• Brand Name: DREAMSTATION BIPAP ST30
• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 21698972
• Report Number: 2518422-2025-103429
• Device Sequence Number: 8730587
• Product Code: MNS
• UDI-Device Identifier: 00606959045606
• UDI-Public: (01)00606959045606
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Device Model Number: DSX1030T11C
• Device Catalogue Number: DSX1030T11C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2017
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown