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

Model Number	DSGH
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted about 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 visualization of particles.There was no report of serious patients, harm or injury.There was no medical intervention required by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed an unknown white dust-like contamination on the cpap seal along with some small black hairs/fibers.During investigation the manufacturer observed a tiny piece of unknown black contamination, inconsistent with sound abatement foam, and a few tiny black hairs/fibers in the bottom of the blower box.A keratin-like substance was observed on the blower box outlet.Evidence of sound abatement foam degradation/breakdown was not observed.The manufacturer used a fitt (foam integrity test tool) and could not confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturers.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes, there was no evidence of sound abatement foam degradation/breakdown and observed multiple contaminants and could not confirm the complaint or address the symptoms specified.

• Brand Name: DREAMSTATION GO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 23483730
• Report Number: 2518422-2025-051530
• Device Sequence Number: 9441069
• Product Code: BZD
• UDI-Device Identifier: 00606959053861
• UDI-Public: (01)00606959053861
• 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
• Report Date (Section B): 11/06/2025

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: DSGH
• Device Catalogue Number: DSGH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• 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