MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION HUMID, CORE PACK, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DSXHCP
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
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.This is related to the device dreamstation humidifier.The patient has alleged to visualization of particles.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The device was returned to the manufacturer.The manufacturer confirmed evidence of foam degradation which was observed in the base unit.There were some secondary findings.During investigation, orange contamination found on the bottom of both base unit and humidifier.Dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, and airpath.Evidence of water ingress on the blower and blower box enclosure.Bio contaminant was found on flip lid seal of humidifier.Corrosion on p4 power port.The manufacturer used a fitt (foam integrity test tool) and was able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found one error codes.The manufacturer applied power to the device and verified airflow.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.

• Brand Name: DREAMSTATION HUMID, CORE PACK, DOM
• 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: 23520186
• Report Number: 2518422-2025-051577
• Device Sequence Number: 18568140
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2017
• 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