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

Model Number	DSXHCP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
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 and mechanical ventilator devices.The manufacturer received information with no allegation.Medical intervention was not specified.The device was returned to the manufacturer's product investigation laboratory for investigation.During the evaluation presence of contamination was confirmed using a fitt (foam integrity test tool).- pil observed mineral deposits / corrosion on the screws at the bottom of the humidifier enclosure.Slight black contamination at the blower seal of the blower box and it is consistent with the keratin contamination observed in (b)(4) v1.During the investigation technician observed 0 errors logged.Pil observed dust/dirt contamination in the device enclosure and airpath, suggesting a source external to the device.Pil observed dust / dirt contamination on the outer surfaces, cracks, and crevices.Pil located a light amount of beige dust or dust contaminant around the outlet port.Pil can confirm the complaint that the device will not turn on/device not functioning, a final test was run on the device in order to check the pressure.The device passed the final test with no errors, signaling that the device¿s pressure was functioning properly.
Additional Manufacturer Narrative
The manufacturer previously reported incorrect information in previous report.The following correction has been updated in this report.Box d and h: single-use device? and manufacture date was corrected in this report.

• 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: 23520279
• Report Number: 2518422-2025-051579
• Device Sequence Number: 9621901
• 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,Followup
• Report Date (Section B): 11/25/2025

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: 04/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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