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

Model Number	DSXH
Medical Device Problem Codes	Degraded (1153); Contamination of Device Ingredient or Reagent (2901); Excessive Heating (4030)
Health Effect - Clinical Codes	Cough (4457); Unspecified Respiratory Problem (4464); Eye Irritation (4803)
Date of Event	06/29/2023
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 dream station humid.The manufacturer received information that the patient alleging nasal, throat, eye irritation and coughing.There was no report of medical intervention.The manufacturer was made aware of this complaint through a representative of the customer.The device was returned to the manufacturer's quality product investigation laboratory for investigation.During the investigation, the manufacturer observed the dust/dirt and fibrous contamination on the flip lid locking mechanism, outside of the blower box, outlet iso port of the humidifier, the air inlet of the motor, and on the heat plate was inconsistent with degraded sound abatement foam contamination.The flip lid locking mechanism was damaged.The presence of contamination within the airpath suggests a source external to the device.Slight black contamination at the blower seal of the blower box and it is consistent with the keratin contamination.The humidifier contained large amounts of mineral deposits in the water chamber and there was evidence of water ingress in the blower box and on the heater plate.The manufacturer used a fitt (foam integrity test tool) and was able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found one error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was evidence of sound abatement foam degradation.The manufacturer can able to confirm the contamination.

• Brand Name: DREAMSTATION HUMID
• 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: 23520313
• Report Number: 2518422-2025-051584
• Device Sequence Number: 21235772
• Product Code: BZD
• UDI-Device Identifier: 00606959022645
• UDI-Public: (01)00606959022645
• 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): 11/11/2025

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: DSXH
• Device Catalogue Number: DSXH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2016
• 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