MAUDE Adverse Event Report: RESPIRONICS, INC. AF541 EE LEAK 1 FULL FACE MASK; CPAP/BIPAP FULL FACE MASK

Model Number	1120912
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	02/05/2021
Type of Reportable Event	Death
Event or Problem Description
The manufacturer was made aware of a patient that was set up on a trilogy evo ventilator and an af 541 mask for covid pneumonia and copd.It was alleged that the patient was discovered in an unresponsive condition, with the tube connecting her face mask to a bipap ventilator detached at the connection point to the mask.It was reported the patient later expired.The manufacturer is currently investigating this event and a follow up report will be filed when the investigation is complete.
Additional Manufacturer Narrative
The af541 mask in use was not retained due to covid-19 contamination.The af541 mask elbow design is a 22mm non-latching conical connection compliant with iso 5356-1.This design is not intended to prevent accidental disconnection, and the af541 mask is contraindicated for use with patients requiring life support ventilation.Based on the information provided, respironics concludes that the af541 mask operated as designed.

• Brand Name: AF541 EE LEAK 1 FULL FACE MASK
• Common Device Name: CPAP/BIPAP FULL FACE MASK
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12780350
• Report Number: 2518422-2021-05748
• Device Sequence Number: 20363332
• Product Code: BZD
• UDI-Device Identifier: 30606959024381
• UDI-Public: 30606959024381
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: Health Professional
• Device Model Number: 1120912
• Device Catalogue Number: 1120912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 EVO (B)(6); TRILOGY EVO VENTILATOR- SN UNKNVENTILATOR CIRCUIT
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female