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

Model Number	DSXHCP
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Dizziness (2194); Sore Throat (2396); Unspecified Respiratory Problem (4464); Sinusitis (4844)
Date of Event	11/30/2023
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 alleging experiencing sore throat and nose, sinus congestion, headaches, dizziness, difficulty breathing.Patient allegedly states a foul odor.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed dust/dirt contamination on top and bottom enclosures, ui panel, rear panel, sd cover flip door, control dial, keypad, pca, blower box upper cap, blower, blower box, blower outlet seal, p4 power connector, dc jack color insert, water tank, flip lid assembly, humidifier bottom enclosure, flip lid seal, lifting tray, dry box seal, humidifier rear panel.Missing accessory module flip door.Pil technician observed no odor coming from the device.Unknown contaminate was observed inside the ui panel.An insect was observed in the airpath of the blower box.Discoloration was observed on the flip lid seal and dry box seal.Liquid ingress was observed on the blower and blower box.A contaminate consistent with keratin was observed on the blower box.Er-2243857 v01 addresses the issue of keratin.The manufacturer used a fitt (foam integrity test tool) and was not able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found 3 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 was not able to confirm the complaint or address the symptoms specified.

• 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: 23520485
• Report Number: 2518422-2025-051591
• Device Sequence Number: 9704444
• Product Code: BZD
• UDI-Device Identifier: 00606959022652
• UDI-Public: (01)00606959022652
• 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: DSXHCP
• Device Catalogue Number: DSXHCP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2019
• 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