MAUDE Adverse Event Report: RESPIRONICS, INC.. AMARA VIEW MASK; MINIMAL CONTACT FULL FACE MASK

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hyperglycemia (1905)

Event Date 09/03/2022

Event Type  malfunction  

Event Description

The manufacturer became aware that a user of an amara view mask with magnetic headgear noticed her sugar levels were rising at 2 am on the nights she was using her magnet mask.The user believes the magnets were effecting her implanted insulin pump and her physician agreed with her.User now has the clips and no longer uses the magnets.The user states her sugar is no longer spiking in early am.No product will be returning for investigation.User is still wearing her amara view mask with the clips now.The manufacturer will continue to monitor complaints for similar issues.This report will be submitted as an initial final report.The manufacturer concludes no further action is needed at this time.

• Brand Name: AMARA VIEW MASK
• Type of Device: MINIMAL CONTACT FULL FACE MASK
• 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: 15819668
• MDR Text Key: 304039675
• Report Number: 2518422-2022-94553
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2022

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female