MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION GO; VENTILATOR, NON-CONTINUOUS (RESPIR ATOR)

Model Number	DSG400S11
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Bronchitis (1752); Headache (1880); Pneumonia (2011); Dizziness (2194); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged skin irritation, respiratory tract irritation, dizziness and/or headache, pneumonia.There was no report of serious or permanent harm or injury.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
Correction to the previous b5: the manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient had alleged skin irritation, respiratory tract irritation, dizziness and/or headache, pneumonia and chronic bronchitis.There was no report of serious or permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacture for evaluation.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Udi related data quality updates only: the udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.In this report, box d, h has been updated/corrected.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient had alleged skin irritation, respiratory tract irritation, dizziness and/or headache, pneumonia and chronic bronchitis.There was no report of serious or permanent harm or injury.No medical intervention was specified by the patient.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Box h: evaluation method code grid.Evaluation results code grid.Conclusion code grid has been updated.

• Brand Name: DREAMSTATION GO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIR ATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18487604
• Report Number: 2518422-2024-01794
• Device Sequence Number: 3664838
• Product Code: BZD
• UDI-Device Identifier: 00606959044425
• UDI-Public: (01)00606959044425
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DSG400S11
• Device Catalogue Number: DSG400S11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 07/29/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 06/04/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown