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

Model Number 1120912

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Respiratory Arrest (4461)

Event Date 02/05/2021

Event Type  Death  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 280532422
• Report Number: 2518422-2021-05748
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 30606959024381
• UDI-Public: 30606959024381
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1120912
• Device Catalogue Number: 1120912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRILOGY EVO (B)(6); TRILOGY EVO VENTILATOR- SN UNKNVENTILATOR CIRCUIT
• Patient Outcome(s): Death
• Patient Sex: Female