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	Nasal congestion (4874)
Date of Event	03/04/2023
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 moldy residue in the tubing and water in chamber has black residue.Patient's symptom was congestion in the morning.There was no report of medical intervention.The manufacturer was made aware of this complaint through a representative of the customer.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer inspected externally observed that humidifier outside bottom of enclosure had unknown brown stains on it.Multiple unknown brown and black contaminants, inconsistent with degraded sound abatement foam, inside of humidifier enclosure.Stains of potential bio-contaminates resembling black mold at the bottom of the humidifier enclosure.Many potential tiny black hairs or fibers throughout humidifier enclosure bottom and a potential large hair or fiber.Green piece of a potential contamination in the corner of the humidifier enclosure bottom.The dry box seal had potential white and brown dust-like contamination on it.The heatshield for the heater plate had brown and gray stains on it and potential mineral deposit stains on the rim of the bottom of the heater plate., indicating possible water ingress.The water tank had potential brown stains on the metal plate and some potential black residue in the corners of the water tank, indicating possible bio-contamination.Five small pieces of black contamination that can potentially be from the black sound abatement foam of the blower box.There is no visible damage or functionality failures of the humidifier, which suggest that the source of contamination was external to the device, except for the 5 pieces of potential black foam.There was no error code found.Pil was not able to confirm the complaint of moldy residue in tubing but could confirm some spots of black residue in water chamber.Pil was not able 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: 23520314
• Report Number: 2518422-2025-051585
• Device Sequence Number: 9613214
• 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: 01/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2023
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2017
• 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