MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION; 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	Insufficient Information (4580)
Date of Event	10/23/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information that a dreamstation st30 device is being returned due to the user passing away.The reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harm reported.Additional information has been requested regarding the details of the reported death.The device has not yet been returned to the manufacturer for evaluation.At this time, there is no customer contact information available; therefore, no good faith-effort attempts can be made, and philips is not able to fully investigate this complaint.If any additional information is received or the device is returned, a supplemental report will be filed.

• Brand Name: DREAMSTATION
• 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: 23407366
• Report Number: 2518422-2025-111377
• Device Sequence Number: 9076047
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: GBX1030S20
• Device Catalogue Number: GBX1030S20
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2023
• 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