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	01/24/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the dreamstation st30 device was being returned due to the user passing away.There is no allegation of malfunction, or that the device caused or contributed to the death.The cause of death was not provided.At this time, the device was returned and a follow-up will be filed when the device evaluation has been completed.
Additional Manufacturer Narrative
The manufacturer previously that the dreamstation st30 device was being returned due to the user passing away.There is no allegation of malfunction, or that the device caused or contributed to the death.The cause of death was not provided.Review of this complaint confirms that there is no allegation or evidence suggesting that the device malfunctioned, failed, or otherwise contributed to the reported outcome.Specifically: no device deficiency (e.G., malfunction, misuse, labeling issue, or performance failure) has been identified.No causal or contributory relationship between the device and the reported death has been established.The available information indicates the death is attributable to factors unrelated to the device.Based on the totality of evidence, this event does not meet the criteria for reportability, as there is no reasonable possibility that the device caused or contributed to the death.Therefore, this case has been reassessed and determined to be non-reportable.The event will continue to be documented and trended per internal quality system requirements.

• 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: 21288979
• Report Number: 2518422-2025-101599
• Device Sequence Number: 9530109
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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
• Date Returned to Manufacturer: 01/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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