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

Model Number	INX1130S19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information stating a patient sadly passed away.The patient was using a bipap avaps30 device, although no information was provided to verify if the device was in use when the patient passed.The reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the reported event.Additionally, there is no other clinical information provided to indicate any causal relationship between the device and the reported death.Also, per report of the event, "there is no allegation that the device contributed to the death." therefore, based on available information the reported death is assessed as not related to the device in this case and did not cause or contribute to a serious injury or death.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm if any malfunction occurred.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer was previously received information stating a patient sadly passed away.The patient was using a bipap avaps30 device, although no information was provided to verify if the device was in use when the patient passed.Despite three good faith-effort attempts on 12/05/2025, 12/11/2025, and 12/31/2025 to the customer/reporter at (b)(6), the device has not yet been returned to the manufacturer for evaluation.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
• 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: 21678981
• Report Number: 2518422-2025-103340
• Device Sequence Number: 20732983
• Product Code: MNS
• UDI-Device Identifier: 00606959425071
• UDI-Public: (01)00606959425071
• 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): 03/03/2026

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
• Device Model Number: INX1130S19
• Device Catalogue Number: INX1130S19
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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