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); Nausea (1970)
Date of Event	06/14/2024
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 previously received information alleging an issue related to a bipap device's sound abatement foam.The patient has alleged power supply, power cord too hot to touch, humidifier not working, machine doesn't turn on, headaches, nausea.There was no report of serious patient harm or injury.The manufacturer using a known good power supply and power cord and confirmed that the device powers on and provides therapy.A heat test was performed on the device, heater plate, and patient port to verify that the temperatures were within the required perimeters required per (b)(4) (v07)-heater plate, (b)(4) (v31)-power supply, ac power cord, and dc power cord.Manufacturer tech performed this test using an asl-5000, a fluke thermometer, a fluke multimeter.The test results showed that the heater plate did not show temperatures within the threshold required, power supply and the power cord showed temperatures within the threshold required.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation observed the material inside the display was damaged, and ui panel is scratched.The keypad on the top enclosure is damaged, the serial label on the bottom enclosure is damaged.A dust/dirt-like contamination is found throughout the device, front panel, top enclosure, rear panel, bottom enclosure.The filter needed to be replaced.Fume-based/dust-like contamination is found on the on the inside of the top enclosure, rear panel and bottom enclosure.An unknown brownish dust-like material is found at the base of the bottom enclosure.A dried accumulation of contamination, most likely mineral deposits, is found on the blower cap, blower, blower box.A heavy layer of dust-like contamination is found on the blower.A considerable amount of black contamination, most likely keratin, is found at the blower box outlet.Observed that the heater plate has dried liquid spots on the bottom, and the screws at the base of the unit have heavy mineral deposits.These findings indicate possible water ingress to the heater plate which is most likely causing it to fail.The manufacturer used a foam integrity test tool and the associated procedure and was not able to confirm the presence of degraded sound abatement foam.The device's downloaded event log was reviewed by the manufacturer and found 31 errors.The manufacturer concludes unable to directly address the symptoms.Manufacturer observe dust/dirt contamination in the airpath, likely from a source external to the device and confirm that humidifier seems not to be working, pil cannot confirm the complaint about the power supply/cord as they were not returned with the device.Manufacturer observed no evidence of degraded sound abatement foam.

• 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: 23520281
• Report Number: 2518422-2025-051582
• Device Sequence Number: 9621902
• 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: 04/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2018
• 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