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 Code	Unspecified Respiratory Problem (4464)
Date of Event	07/13/2023
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 dreamstation humid.The manufacturer received humidifier with complaint of runny nose after using device.No other peripherals or accessories were returned with the device.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed evidence of sound abatement foam degradation which was observed in the base unit.Pil can confirm sound abatement foam degradation, but it is unable to determine if it is the cause of the patient¿s complaint.Pil finds that other contaminations located in this investigation were sourced from external environmental conditions.Secondary findings: dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, humidifier enclosure, and airpath, suggesting a source external to the device.Humidifier flip lid seal was severely yellowed.Slight black contamination at the blower seal of the blower box and it is consistent with the keratin contamination observed.Pil retrieved the error log.There were 5 instances of continue error codes were observed.Pil is unable to address the symptoms described.Pil can confirm the presence of contamination in the airpath.
Additional Manufacturer Narrative
The manufacturer previously reported incorrect information in previous report.The following correction has been updated in this report.In box h: labeled for single use has been 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: 23520102
• Report Number: 2518422-2025-051575
• Device Sequence Number: 15879192
• 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: 03/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• 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: 02/26/2019
• 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