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

Model Number	DSXH
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	02/15/2023
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 that the patient alleging upper respiratory infection.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.The manufacture inspected and observed dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, and airpath, suggesting a source external to the device.Slight black contamination at the blower seal of the blower box is consistent with the keratin contamination observed.The manufacturer was not observed the sound abatement foam degradation/breakdown.The device's event logs were downloaded and reviewed by manufacturer.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.The manufacturer observed dust contamination and unable to address the symptoms described.Manufacturer can confirm the presence of contamination in the airpath.

• Brand Name: DREAMSTATION HUMIDIFIER
• 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: 23391718
• Report Number: 2518422-2025-049994
• Device Sequence Number: 13222672
• 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): 10/27/2025

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: 02/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2016
• 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