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 Kidney or Urinary Problem (4503)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
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 a complaint of chronic kidney disease.No other peripherals or accessories were returned with the device.Patient stated that soclean 2 was used twice per week on average.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed evidence of sound abatement foam degradation/breakdown was observed in this device.Pil observed multiple unknown brown and black, contaminants and some short black hairs inside of humidifier box and on dry box seal.Pil observed a small brown stain on the flip lid seal.Pil observed potential black water stains on the bottom of the back panel and on the bottom of the humidifier enclosure.Pil observed slight heat mark on the heater plate.Pil observed a large heat mark on the pan on the bottom of the water tank.The contamination found in the humidifier box are considered not to be in the airpath.There is no visible damage or functionality failures of the humidifier, which suggest that the source of contamination was external to the device.Upon visual inspection, pil observed that the heater tube had no outstanding defects.They were 6 errors logged.
Additional Manufacturer Narrative
The manufacturer previously reported on this device in mdr 2518422-2021-06447.This report was submitted for the dreamstation humidifier.The base device associated with this humidifier is reported under mdr 2518422-2021-06447.At this time of investigation, it has been determined that all reporting activities will be carried out in mdr 2518422-2022-03446.Therefore, this report was submitted as a duplicate report of the previously submitted 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: 23520316
• Report Number: 2518422-2025-051578
• Device Sequence Number: 15856364
• 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): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown