Amara View Amara View Mask with Headgear, FitPackRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959009288), received between Dec 5, 2022 and Dec 20, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE THAT A USER OF AN AMARA VIEW MASK WITH MAGNETIC HEADGEAR ALLEGES HIS HEART BEAT FLUCTUATES AND HE NOW BELIEVES THAT IT COULD BE DUE TO HIS MASK. USER HAS HAD THREE DEFIBRILLATORS SINCE 2015. THE MOST RECENT REPLACEMENT WAS TWO YEARS AGO IN 2020. USER DOES NOT THINK THE MAGNETS AFFECTED HIS DEFIBRILLATOR. THE DME HAS SENT THE USER CLIPS AND FOR SEVERAL DAYS IT WORKED FINE. NOW HIS CPAP QUIT WORKING WHICH IS OVER FIVE YEARS OLD, SO USER IS GETTING HIS MACHINE REPLACED AT THE DME. THERE WAS NO SERIOUS HARM OR INJURY REPORTED. NO MASK OR HEADGEAR WILL BE RETURNING. USER NOW HAS CLIPS AND WILL CONTINUE USING THE MASK AND HEADGEAR WITH CLIPS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013335 ↗
• MalfunctionDec 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER RECEIVED INFORMATION THAT A USER OF AN AMARA VIEW MASK WITH MAGNET HEADGEAR ALLEGES THE MASK WITH MAGNETS HAS REDUCED THE LIFETIME OF HIS DEFIBRILLATOR BY 1.5 YEARS. THE USER STATED THE DEFIBRILLATOR WAS MAKING A SOUND LIKE AN ALARM FOR THIRTY SECONDS OR MORE. THE USER WAS INSTRUCTED TO ORDER THE NON MAGNETIC CLIPS FOR HIS MASK AND HEADGEAR. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO PRODUCT WAS RETURNED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936333 ↗
• MalfunctionDec 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER RECEIVED INFORMATION THAT A USER OF AN AMARA VIEW MASK WITH MAGNET HEADGEAR HAS A CONTRAINDICATION AND WOULD LIKE TO KNOW WHAT IS THE NEXT STEP. THE USER WAS ADVISED TO ORDER THE TALON CLIP AND GIVEN THE PART NUMBER FOR ORDERING FROM HIS PROVIDER. THE USER STATED THE PROVIDER DOES NOT HAVE THEM AND DID NOT OFFER TO ORDER THEM. WE GAVE THE USER AN OPTION WITH FREEDOM LINK FOR ANOTHER PROVIDER. THE USER WOULD NOT GIVE ANY ADDITIONAL INFORMATION . ADDITIONAL ATTEMPTS TO GAIN INFORMATION WERE UNSUCCESSFUL. NO PRODUCT WAS RETURNED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931816 ↗
• InjuryDec 5, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  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.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 15920611 ↗