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

Model Number	1090602
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Partial Hearing Loss (4472)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an end user with ear implants experienced hearing loss while using the amara view face mask with magnetic clips.The user allegedly used the mask for two years and noticed a decline in his hearing.The care facility for patient care has changed the mask to one without magnets.No product will be returned for investigation.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

• 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: 15835518
• Report Number: 2518422-2022-94792
• Device Sequence Number: 12110154
• Product Code: BZD
• UDI-Device Identifier: 00606959009134
• UDI-Public: 00606959009134
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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: 1090602
• Device Catalogue Number: 1090602
• 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: 11/14/2022
• Initial Report FDA Received Date: 11/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown