MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DSX400H11C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Unspecified Hepatic or Biliary Problem (4493); Skin Inflammation/ Irritation (4545)
Date of Event	01/16/2024
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.This report was related to a dreamstation cpap pro device.The manufacturer received information from the patient alleging nose irritation, skin irritation, respiratory tract irritation, hypersensitivity, inflammatory response, reduced cardiopulmonary reserve, liver disease/toxicity, asthma (new or worsening), and lung disease.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer.However, capa pr 7211 documents the investigation into similar complaints, correction/removal activities have been initiated (refer to h.9), and complaint code trending is reviewed on a periodic basis to evaluate field quality performance, and as an input to risk management activities.Should additional information be received, a supplemental report will be filed.

• Brand Name: DREAMSTATION CPAP PRO
• 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: 24108048
• Report Number: 2518422-2026-100151
• Device Sequence Number: 5815958
• Product Code: BZD
• UDI-Device Identifier: 00606959025608
• UDI-Public: (01)00606959025608
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/19/2026

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: DSX400H11C
• Device Catalogue Number: DSX400H11C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2017
• 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