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

Model Number	1090623
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Abscess (1690); Pain (1994)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A voluntary medwatch was received by the manufacturer with the user alleging an abscess secondary to root death that required root canal surgery.The user states repositioning of her amara view mask caused constant pressure on the incisor root area which caused tooth injury leading to the root canal.The user has worn the same style mask for 5 years.The manufacturer requested the mask for investigation.The investigation is on-going.A follow up final report will be submitted once the investigation is complete.

• Brand Name: AMARA VIEW MASK
• 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: 13313891
• Report Number: 2518422-2022-00766
• Device Sequence Number: 4663125
• Product Code: BZD
• UDI-Device Identifier: 00606959009219
• UDI-Public: 00606959009219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1090623
• Device Catalogue Number: 1090623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 01/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESMED CPAP SN UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female