MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP S/T 30 W/HEATED HUMIDIFIER, GB; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	GBX1030H20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	05/21/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging the patient has sadly passed away.There is no allegation that the device contributed to the death.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION BIPAP S/T 30 W/HEATED HUMIDIFIER, GB
• 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: 22096664
• Report Number: 2518422-2025-106101
• Device Sequence Number: 8022678
• Product Code: MNS
• UDI-Device Identifier: 00606959045064
• UDI-Public: (01)00606959045064
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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
• Device Model Number: GBX1030H20
• Device Catalogue Number: GBX1030H20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2022
• 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