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

Model Number	GBX1030S20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging an issue related to a dreamstation st30 device.The patient has passed away.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION ST30
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 23557496
• Report Number: 2518422-2025-051954
• Device Sequence Number: 9764401
• Product Code: MNS
• UDI-Device Identifier: 00606959425989
• UDI-Public: (01)00606959425989
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: GBX1030S20
• Device Catalogue Number: GBX1030S20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown