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	Headache (1880)
Date of Event	06/16/2023
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 patient has alleged headaches, no power supply, tubing or mask was supplied with the device.There was no report of serious patient harm or injury.The manufacturer using fitt (foam integrity test tool) took per fitt document to test the sound abatement foam for degradation and breakdown.The manufacturer did find evidence of sound abatement foam degradation which was observed in the base unit.The manufacturer can confirm sound abatement foam degradation.During evaluation, secondary findings dust/dirt contamination on the flip lid locking mechanism, outside of the blower box, outlet iso port of the humidifier, and on the air inlet of the motor was inconsistent with degraded sound abatement foam contamination and care orchestrator data available suggesting that user was 100% compliant with device usage.The foam using the fitt tool, the foam was determined to be degraded.Slight black contamination found at the blower seal of the blower box, and it is consistent with the keratin contamination observed.Dust/dirt contamination found around the heater plate.The manufacturer is unable to confirm the complaint regarding headaches.The manufacturer can confirm there was evidence of sound abatement foam degradation found within the device.The manufacturer can confirm the presence of contamination in the airpath.The manufacturer can confirm the presence of water ingress in the blower box and blower suggesting the use of non-distilled water.

• 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: 23520352
• Report Number: 2518422-2025-051588
• Device Sequence Number: 21249408
• 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: 01/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2016
• 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