MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION ST30; VENTILATORY SUPPORT SYSTEM

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	09/04/2024
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information that a patient passed away and the device was going to be returned as it was no longer in use by the customer.There is no allegation that the device contributed to the patient outcome, however limited information has been provided at this time.The manufacturer's investigation is ongoing.A follow up report will be submitted when the investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported that a patient passed away and the device was going to be returned as it was no longer in use by the customer.There is no allegation that the device contributed to the patient outcome, however limited information has been provided at this time.The device was returned and evaluated by a third-party service center.The device was found to pass all device testing.No abnormalities were found.The device performed as designed and as intended.The following codes have been updated as follows: evaluation method code - testing of actual/suspected device.Evaluation results code - analysis of information provided by user/third party.Component grid - no information.Conclusion code - no problem detected.

• Brand Name: DREAMSTATION ST30
• Common Device Name: VENTILATORY SUPPORT SYSTEM
• 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: 20248740
• Report Number: 2518422-2024-100696
• Device Sequence Number: 7235069
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: Other
• Device Model Number: GBX1030S20
• Device Catalogue Number: GBX1030S20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown