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	Insufficient Information (4580)
Date of Event	09/01/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient with a dreamstation st30 has passed away.The reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported; therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.Additional information has been requested regarding the details of the reported death.
Additional Manufacturer Narrative
The manufacturer received information alleging a patient with a dreamstation st30 has passed away.The reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported; therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.Additional information has been requested regarding the details of the reported death.The dreamstation st30 was returned to the manufacturer service center for evaluation.No errors were found; therefore, no components were replaced to correct a malfunction.The customer complaint was not addressed.If any additional information is received, a follow-up report will be filed.

• Brand Name: DREAMSTATION 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22958803
• Report Number: 2518422-2025-109619
• Device Sequence Number: 13140439
• 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,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2021
• 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