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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
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 received information patient stated the replacement ds1 turned off during use and complained the heated tubing was too hot and burned the patient¿s skin when touched.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device was returned to the manufacturer's service center for further evaluation.During the evaluation of the device at the manufacturer service center, the device was visually inspected dust-like contamination on the flip lid, the bottom cover, the iso (international organization of standardization) port, the iso port cover, and the heater plate.During the evaluation of the device at the manufacturer service center was not able to confirm the complaint of the whole device feeling hot or the complaint of the humidifier not working.The manufacturer service center concludes the complaint of the device not turning on or the complaint of the device turning off during use.Pil was not able to confirm the complaint of a burning smell and evidence of melting, warping or voids/gaps in the enclosure.The manufacturer service center concludes the complaint could not address the symptoms specified.
Additional Manufacturer Narrative
The manufacturer previously reported incorrect information in previous report.The following correction has been updated in this report.Box d: suspect medical device: operator of device (rfb) was updated (previously it was wrong).

• 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: 23520183
• Report Number: 2518422-2025-051576
• Device Sequence Number: 9704890
• 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): 11/25/2025

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: 01/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2020
• 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