MAUDE Adverse Event Report: RESPIRONICS, INC. COMFORTFULL 2; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	CN1024261
Medical Device Problem Codes	Material Integrity Problem (2978); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer previously reported the manufacturer received information alleging a patient experienced discomfort and leaks from a comfortfull mask.During clinical use of the comfort full 2 niv (non-invasive ventilation) interface, it was reported that the patient complained of discomfort and was not compliant with niv use.Blood gas labs were conducted revealing co2 retention.Further examination by the physician found that the niv interface would not fit the patient correctly and despite adjustment, unintentional leak was noted resulting in insufficient therapeutic delivery from the device (unspecified make/model).It was further reported that the patient was noted to have become more compliant and blood gas results showed improvement, subsequently the physician decided not to replace the niv interface.It was alleged however that noted blood gas improvements were not significant, resulting in a prolonged hospital stay for the patient.The allegation has been reviewed by a pms clinical expert, and it has been determined there is sufficient evidence to pronounce a serious injury, as defined in 21 cfr 803.3(w).No causal relationship of the device to the patient adverse event was noted, however contribution was confirmed: foreseeable unintentional use error - improper mask selection/fitment resulting in unintentional leak and degraded device therapy.The device has not yet been returned.A follow up report will be filed if there is any additional information.The manufacturer received information via a good faith effort from the site engineer stating the mask has been discarded and cannot be returned.A final report is being submitted.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.Based upon the information currently provided and available, during clinical use of the comfort full 2 niv (non-invasive ventilation) interface, it was reported that the patient complained of discomfort and was not compliant with niv use.Blood gas labs were conducted revealing co2 retention.Further examination by the physician found that the niv interface would not fit the patient correctly and despite adjustment, uninentional leak was noted resulting in insufficient therapeutic delivery from the device (unspecified make/model).It was further reported that the patient was noted to have become more compliant and blood gas results showed improvement, subsequently the physician decided not to replace the niv interface.It was alleged however that noted blood gas improvements were not significant, resulting in a prolonged hospital stay for the patient.
Event or Problem Description
The manufacturer received information alleging a patient experienced discomfort and leaks from a comfortfull mask.During clinical use of the comfort full 2 niv (non-invasive ventilation) interface, it was reported that the patient complained of discomfort and was not compliant with niv use.Blood gas labs were conducted revealing co2 retention.Further examination by the physician found that the niv interface would not fit the patient correctly and despite adjustment, unintentional leak was noted resulting in insufficient therapeutic delivery from the device (unspecified make/model).It was further reported that the patient was noted to have become more compliant and blood gas results showed improvement, subsequently the physician decided not to replace the niv interface.It was alleged however that noted blood gas improvements were not significant, resulting in a prolonged hospital stay for the patient.The allegation has been reviewed by a pms clinical expert, and it has been determined there is sufficient evidence to pronounce a serious injury, as defined in 21 cfr 803.3(w).No causal relationship of the device to the patient adverse event was noted, however contribution was confirmed: foreseeable unintentional use error - improper mask selection/fitment resulting in unintentional leak and degraded device therapy.The device has not yet been returned.A follow up report will be filed if there is any additional information.
Additional Manufacturer Narrative
The manufacturer previously reported the manufacturer received information via a good faith effort from the site engineer stating the mask has been discarded and cannot be returned.A final report is being submitted.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.Based upon the information currently provided and available, during clinical use of the comfort full 2 niv (non-invasive ventilation) interface, it was reported that the patient complained of discomfort and was not compliant with niv use.Blood gas labs were conducted revealing co2 retention.Further examination by the physician found that the niv interface would not fit the patient correctly and despite adjustment, unintentional leak was noted resulting in insufficient therapeutic delivery from the device (unspecified make/model).It was further reported that the patient was noted to have become more compliant and blood gas results showed improvement, subsequently the physician decided not to replace the niv interface.It was alleged however that noted blood gas improvements were not significant, resulting in a prolonged hospital stay for the patient.The previous report did not include the final coding.The coding in box h: device manufacturers has been updated.

• Brand Name: COMFORTFULL 2
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23689400
• Report Number: 2518422-2025-112190
• Device Sequence Number: 9123836
• Product Code: CBK
• UDI-Device Identifier: 00606959041820
• UDI-Public: (01)00606959041820
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CN1024261
• Device Catalogue Number: CN1024261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/18/2026; 04/23/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 04/17/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown