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

Model Number	BRX1130S18
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information regarding a report that the patient was using the device normally, but around 5:00 am the circuit disconnected, and the patient was without therapy for approximately 30 minutes.This caused a drop in oxygen saturation (unspecified), and it was stated that "possibly for this reason, the patient suffered a cardiac arrest." it was reported that medical procedures were performed (unspecified), and the patient was treated and is recovering.Per report of the event, it is unclear whether a disconnection alarm was triggered and if this alarm was silenced.It was reported that the device logs will be retrieved for investigation.The device has not yet been returned to the manufacturer for evaluation.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.

• 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: 24576347
• Report Number: 2518422-2026-009153
• Device Sequence Number: 18431410
• Product Code: MNS
• UDI-Device Identifier: 00606959427211
• UDI-Public: (01)00606959427211
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BRX1130S18
• Device Catalogue Number: BRX1130S18
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2022
• 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: Life Threatening
• Patient Sex: Unknown