MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION ST30, GB; 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	10/26/2024
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging an unspecified malfunction resulting in a patient death.Device settings were provided as the following: mode st, ipap 30, epap 6, ti.1.3, rate 16, rise 1, ramp off, humidification 3, trigger auto trak, 3 l/min via o2 concentrator.Alarms were noted as being turned off.The cause of death was reported as currently awaiting a coroner's report.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging an unspecified malfunction resulting in a patient death.Device settings were provided as the following: mode st, ipap 30, epap 6, ti.1.3, rate 16, rise 1, ramp off, humidification 3, trigger auto trak, 3 l/min via o2 concentrator.Alarms were noted as being turned off.The cause of death was reported as currently awaiting a coroner's report.Despite three good faith effort attempts to christopher.Riley1@nhs.Net on 15/04/2025, 18/04/2025 and 21/04/2025, the device has not yet been returned to the manufacturer for evaluation.An additional response was sent via email on 23/04/2025 with no follow-up from the customer.At this time, no further investigation can be completed.If any additional information is received at a later date, a supplemental report will be filed.

• Brand Name: DREAMSTATION ST30, 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: 21719312
• Report Number: 2518422-2025-103505
• Device Sequence Number: 9437502
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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?: Yes
• Device Model Number: GBX1030S20
• Device Catalogue Number: GBX1030S20
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Sex: Male