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	Headache (1880); Sore Throat (2396)
Date of Event	07/05/2023
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 headaches and sore throat related to a dreamstation humid.There was no report of medical intervention.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed the dust/dirt contamination found at the air inlet, iso port, on the front and back panel, motor casing/impellers, and blower box was inconsistent with degraded sound abatement foam contamination.The presence of contamination throughout the airpath, suggests a source external to the device.Mineral spots consistent with water ingress were found on the blower box and motor casing.Slight black contamination at the blower seal of the blower box appears consistent with the keratin contamination.The dust/dirt contamination found within the humidifier unit, on the iso port, within the dry box and dry box assembly, on the dry box seal, and on the edge of the heater plate.Mineral spots consistent with the use of non-distilled water was found within the humidifier unit on the dry box seal and heater plate.Contamination consistent with metallic corrosion was found on the bottom of the humidification unit and on the heater plate.Pil can confirm the presence of multiple contaminants that are not consistent with degraded sound abatement foam from the secondary findings.The manufacturer 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 9 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 was unable to 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: 23520484
• Report Number: 2518422-2025-051590
• Device Sequence Number: 13187820
• 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: 03/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• 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