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	Arrhythmia (1721); Dyspnea (1816)
Date of Event	07/30/2023
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 cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleging difficulty breathing/shortness of breath and an irregular heartbeat.There was no medical intervention required by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed visible evidence of sound abatement foam degradation and breakdown in the blower box, blower, and iso port.Small amounts of dust/dirt contamination inconsistent with degraded sound abatement foam found throughout device enclosure, outside of the blower box.Evidence of water ingress found in the bottom of the blower box.Contamination consistent with degraded sound abatement foam on the air outlet port and throughout the airpath.When removing the screws holding the bottom cover in place, one of the threads broke off where a corroded screw was housed.The broken thread and screw were placed in a clear bag attached to the device.Pil can confirm evidence of degraded sound abatement foam particles in the airway of both the device and its humidifier.The manufacturer concludes, there was evidence of sound abatement foam degradation/breakdown and observed multiple contaminants and was not able to confirm the complaint or address the symptoms specified.
Additional Manufacturer Narrative
The manufacturer previously reported on this device in mdr 2518422-2022-05304.This report was submitted for the dream station humidifier.The base device associated with this humidifier is reported under mdr 2518422-2022-05304.At this time of investigation, it has been determined that all reporting activities will be carried out in mdr 2518422-2022-05304.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: 23520312
• Report Number: 2518422-2025-051583
• Device Sequence Number: 21235771
• 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: 01/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2023
• 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: 07/10/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown