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

Model Number	1116680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Numbness (2415); Cognitive Changes (2551)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information related to a dreamwear utn mask.The patient alleges very tender lightheaded brain fog for a few days, has to use ice on his face sometimes.The patient alleges seeing a doctor, and it was determined that it is his trigeminal nerve and causing numbness from his ears to his chin.The patient alleges he thought that he had a stroke has had mri's and cat scans, he lays on his side.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information related to a dreamwear utn mask.The patient alleges very tender light headed brain fog for a few days, has to use ice on his face sometimes.The patient alleges seeing a doctor, and it was determined that it is his trigeminal nerve and causing numbness from his ears to his chin.The patient alleges he thought that he had a stroke has had mri's and cat scans, he lays on his side.Additional information: this has been determined as a non serious injury by the clinical assessment.

• Brand Name: DREAMWEAR MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 22815473
• Report Number: 2518422-2025-109151
• Device Sequence Number: 9014095
• Product Code: BZD
• UDI-Device Identifier: 00606959029194
• UDI-Public: 00606959029194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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: 1116680
• Device Catalogue Number: 1116680
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 03/16/2026; 06/01/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown