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

Model Number	1121493
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of an event that occurred while a patient was being placed on niv therapy.The user alleged that the af541 ee mask valve allowing a controlled leak did not function properly.There was no harm or injury to the patient.The manufacturer is currently investigating this event and a follow up report will be filed when the investigation is complete.
Additional Manufacturer Narrative
The manufacturer requested return of mask for investigation.No product was returned.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 should also not be used on 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.This mask requires a separate exhalation device.There was no harm or injury.The manufacturer concludes no further action is necessary.

• Brand Name: AF541 EE LEAK 1 FULL FACE MASK
• Common Device Name: CPAP/BIPAP FULL FACE MASK: PRODUCT CODE: BZD
• 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: 13515449
• Report Number: 2518422-2022-03866
• Device Sequence Number: 14777274
• Product Code: BZD
• UDI-Device Identifier: 00606959024496
• UDI-Public: 00606959024496
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1121493
• Device Catalogue Number: 1121493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown