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

Model Number	GBX1030S20
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2024
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information that a rental, dreamstation st30, device is returning due to a patient passing away.There is no allegation that the device contributed to the death.The complaint review has determined that due to insufficient information this will be reported.Although there is not an allegation that the device caused or contributed to the mentioned "death".The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The device was returned to a third-party service center for evaluation.Evaluation of the device indicated the device passed and all testing without any faults found.Based on the service evaluation of the device, there is no evidence indicating a reportable malfunction occurred or that therapy was affected.The investigation findings did not uncover any details that would change or modify the risk of the device.

• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20907025
• Report Number: 2518422-2024-105419
• Device Sequence Number: 4120148
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: Other
• Device Model Number: GBX1030S20
• Device Catalogue Number: GBX1030S20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown