MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AMARA VIEW MASK; CPAP/BIPAP FULL FACE MASK

Model Number	1090670
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
The manufacturer became aware that a user alleges the exhalation port from her amara view mask with magnetic headgear was blowing air toward her eyes when on her pap device for sleep apnea.The user alleges that this airflow caused corneal erosions and eye disease.The user stated she altered the mask by drilling her own exhalation port in the bottom of the mask but it is unclear if she occluded the original exhalation port.The user mailed her mask into philips but did not provide any reference numbers in packaging.The user no longer wants replacement clips because she no longer is using the amara view mask.The user stated she has a pacemaker.No mask or headgear will be returning for investigation.This will be an initial-final report.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.
Additional Manufacturer Narrative
The manufacturer previously became aware that a user alleges the exhalation port from her amara view mask with magnetic headgear was blowing air toward her eyes when on her pap device for sleep apnea.The user alleges that this airflow caused corneal erosions and eye disease.The user stated she altered the mask by drilling her own exhalation port in the bottom of the mask but it is unclear if she occluded the original exhalation port.The user mailed her mask into philips but did not provide any reference numbers in packaging.The user no longer wants replacement clips because she no longer is using the amara view mask.The user stated she has a pacemaker.In the previous report, section h1 type of reportable event, was inadvertently selected as "other".It has been corrected to "serious injury" on this report.

• Brand Name: AMARA VIEW MASK
• Common Device Name: CPAP/BIPAP FULL FACE MASK
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 15920611
• Report Number: 2518422-2022-101053
• Device Sequence Number: 14567787
• Product Code: BZD
• UDI-Device Identifier: 00606959009288
• UDI-Public: 00606959009288
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: 1090670
• Device Catalogue Number: 1090670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female