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	Sore Throat (2396); Cancer (3262); Cough (4457); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A device was returned to manufacturer's product investigation laboratory 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 that the patient alleging two skin cancers on face by nasal area, cough, and throat irritation.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation, evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The manufacturer inspected externally and internally, observed liquid ingress and mineral spots on blower and blower box.Dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, airpath, dirt contamination on flip lid seal, and indeterminate contamination throughout enclosure suggesting a source external to the device.Slight black contamination at the blower seal of the blower box is consistent with the keratin contamination observed.The manufacturer used a fitt (foam integrity test tool) and was not able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer concludes there was no evidence of sound abatement foam degradation in the device and they were unable to directly address the symptoms.
Additional Manufacturer Narrative
Section h is corrected/updated in this report.Section h: - h6 health effect - clinical code are corrected/updated (previously reported as no clinical signs, symptoms or conditions).In section h: - h6 health effect - impact is corrected/updated to serious injury/illness/impairment (previously reported as no health consequences or impact).
Additional Manufacturer Narrative
The manufacturer previously reported on this device in mdr 2518422-2022-03446.This report was submitted for the dreamstation humidifier.The base device associated with this humidifier is reported under mdr 2518422-2022-03446.At this time of investigation, it has been determined that all reporting activities will be carried out in mdr 2518422-2022-03446.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: 23520276
• Report Number: 2518422-2025-051581
• Device Sequence Number: 13187945
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,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: 03/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 01/21/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/11/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown