MAUDE Adverse Event Report: RESPIRONICS, INC. AF541 EE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1120910
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	Hypoxia (1918)
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was made aware of an allegation that a patient with a medical history of spastic quadriplegic cerebral palsy and epilepsy had a spastic movement while non- invasive ventilation (niv) and the af541 mask were in use, which caused disconnection between the mask and the circuit, and cyanosis with subsequent low oxygen saturation levels.The patient required bagging with 100% oxygen to restore the oxygen saturation to an acceptable level, and niv with the mask was reinstituted.The patient was covid+, and was in an isolation room.There was no serious or permanent injury.The date of the event is unknown.No further information was provided by the reporting facility.The mask was discarded by the facility.No lot number was provided.The manufacturer is unable to determine a fault with the mask caused or contributed to the event.This mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single use in the hospital/institutional environment only.The mask is to be used on patients (>(b)(6)) for whom cpap or bi-level therapy has been prescribed.This mask is contraindicated in patients who need life support ventilation, who are taking a prescription drug that may cause vomiting, or on patients that are uncooperative, unresponsive, or unable to remove the mask by themselves.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: AF541 EE
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11517153
• Report Number: 2518422-2021-00678
• Device Sequence Number: 17126547
• Product Code: BZD
• UDI-Device Identifier: 30606959024367
• UDI-Public: 30606959024367
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1120910
• Device Catalogue Number: 1120910
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR