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

Model Number	1090624
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was notified by an end user that the magnets in the headgear were causing pressure and bleeding on her molars.She reported one of the teeth had a gold metal cap.There was no report of serious or permanent injury and no medical intervention was required.No product was returned.The user was advised to speak to her provider or dentist.This mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.The mask is to be used on patients (>66lbs/30kg) for whom cpap or bi-level therapy has been prescribed.The user is warned, "consult a physician or dentist if you encounter tooth, gum, or jaw soreness.Use of a mask may aggravate an existing dental condition." based on the information available, the manufacturer concludes no further action is necessary.
Additional Manufacturer Narrative
The manufacturer previously reported an incorrect device problem code, 3189-no apparent adverse event, on the previously submitted report.The device problem code is corrected on this report.

• Brand Name: AMARA VIEW
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 15328934
• Report Number: 2518422-2022-77760
• Device Sequence Number: 6484962
• Product Code: BZD
• UDI-Device Identifier: 00606959009219
• UDI-Public: 00606959009219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: Lay User/Patient
• Device Model Number: 1090624
• Device Catalogue Number: 1090624
• Device Lot Number: 77192932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 04/13/2023
• 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: Female