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

Model Number	1133424
Medical Device Problem Codes	Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/02/2021
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging that a patient was receiving assisted ventilation from a trilogy ventilator device.The patient suffered from cardiac arrest when the dreamwear mask became disconnected from the patient and the patient subsequently expired.The manufacturer has requested the return of the mask for evaluation, but the device has not yet been received.At this time, we are unable to confirm the allegation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging that a patient was receiving assisted ventilation from a trilogy ventilator device.The patient suffered from cardiac arrest when the dreamwear mask became disconnected from the patient, and the patient subsequently expired.The mask was returned to the manufacturer's quality product investigation lab for evaluation and was found to meet manufacturer specifications.No defects or abnormalities were observed.The manufacturer concludes the mask did not cause or contribute to the reported event.
Additional Manufacturer Narrative
The manufacturer previously submitted this report with incomplete evaluation, and it has been reported as: the manufacturer previously reported receiving information alleging that a patient was receiving assisted ventilation from a trilogy ventilator device.The patient suffered from cardiac arrest when the dreamwear mask became is connected from the patient, and the patient subsequently expired.During the investigation, the manufacturer observed that mask assembly had no physical damage or defects and was in a normal design orientation.The manufacturer observed foreign white particles on the silicone and faceplate areas of the cushion.This was indicative of patient contamination caused by patient usage.The exhalation flapper valves were checked by flipping the cushion.Both flapper valves moved freely.The dreamstation was powered up and pressure was applied to the mask assembly.The exhalation flapper valves sealed as designed.No leaks were observed or heard.During testing if either flapper valve was pressed in, once released, it sealed as designed.The manufacturer could not confirm the complaint of "mask failed" and could not determine the root cause for the complaint.Section h6: type of investigation, findings and conclusion codes has been updated/corrected.

• Brand Name: DREAMWEAR FULL FACE MASK
• 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 11657276
• Report Number: 2518422-2021-01071
• Device Sequence Number: 17024228
• Product Code: BZD
• UDI-Device Identifier: 00606959046214
• UDI-Public: 00606959046214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1133424
• Device Catalogue Number: 1133424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/18/2021; Not provided
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/19/2021; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRILOGY 100 VENTILATOR SERIAL NUMBER (B)(4); TRILOGY 100 VENTILATOR SERIAL NUMBER (B)(4)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male