MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMWEAR UTN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1116724
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Abrasion (1689); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer was contacted and received information alleging patient not utilizing cpap protection cover and bleeding of the cheek.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 and there is no contact information for the initial reporter to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
A clinical evaluation of the harm alleged by the patient was reviewed and did not meet the definition of a serious injury.
Additional Manufacturer Narrative
Previously reported as, the manufacturer was contacted and received information alleging patient not utilizing cpap protection cover and bleeding of the cheek.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 and there is no contact information for the initial reporter to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In this report, box b: adverse event or product problem (describe event or problem) as 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 patient has alleged to patient not utilizing cpap protection cover and bleeding of the cheek.No medical intervention was required by the patient.The device was returned to third party service center and evaluated.Evaluation result stated that no foam particles were observed.The manufacturer is submitting a final report at this time.If any additional information becomes available to the manufacturer at a later date, an addendum to this final report will be filed, box d: suspect medical device (operator of device), box g: all manufacturers (report source), box h: device manufacturers (evaluation method code grid, evaluation results code grid, component code grid, conclusion code grid) have been corrected/updated.

• Brand Name: DREAMWEAR UTN
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17455522
• Report Number: 2518422-2023-18247
• Device Sequence Number: 14099279
• Product Code: BZD
• UDI-Device Identifier: 00606959040298
• UDI-Public: 00606959040298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: Other
• Device Model Number: 1116724
• Device Catalogue Number: 1116724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/05/2023; 08/07/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/25/2023; 10/29/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male