MAUDE Adverse Event Report: RESPIRONICS INC AF541 EE LEAK 1; 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)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging that while a patient was connected to a bilevel positive airway pressure (bipap) device, the mask became disconnected from the circuit and the patient became unresponsive and hypoxemic.The patient subsequently required manual resuscitation with an ambu bag to correct the hypoxemia.No date of event was provided.The mask is not available for investigation.The mask was discarded by the facility.No lot number was provided.The manufacturer is unable to determine if 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 (>40lbs/20kg) 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 LEAK 1
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11517374
• Report Number: 2518422-2021-00784
• Device Sequence Number: 14436079
• 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): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare 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
• Was Device Available for Evaluation?: No
• 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