BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMARA FULL FACE MASK

    MDR report key: 14193079 · Received April 25, 2022

    Report

    Report Number
    2518422-2022-13896
    Event Type
    Death
    Date Received
    April 25, 2022
    Date of Event
    January 23, 2021
    Report Date
    December 6, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER REQUESTED LOT NUMBER AND PART NUMBER OF THE MASK, BUT NO INFORMATION WAS AVAILABLE. NO PRODUCT WAS RETURNED. THE AMARA FULL FACE MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THIS MASK SHOULD ALSO NOT BE USED ON PATIENTS WHO NEED LIFE SUPPORT VENTILATION, WHO ARE TAKING PRESCRIPTION MEDICATION THAT MAY CAUSE VOMITING, OR ON PATIENTS WHO ARE UNCOOPERATIVE, OBTUNDED, UNRESPONSIVE, OR UNABLE TO REMOVE THE MASK. AN EXHALATION PORT IS BUILT INTO THE MASK SO A SEPARATE EXHALATION PORT IS NOT REQUIRED. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED MEDICAL DEVICE PROBLEM CODE: 3190 (INSUFFICIENT INFORMATION). AFTER REVIEW, THE MEDICAL DEVICE PROBLEM CODE SHOULD BE 4001 (PATIENT DEVICE INTERACTION PROBLEM). THE MANUFACTURER PREVIOUSLY REPORTED THIS ON MDR 2518422-2022-04685 AS WELL.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN AMARA FULL FACE MASK CONTRIBUTED TO DEATH OF A END USER. THE MASK WAS REPORTEDLY TAKEN OUT OF THE PACKAGING AND PLACED ON THE END USER BY A HEALTH CARE PROFESSIONAL WITH THE PROTECTIVE COVERING STILL ATTACHED TO THE MASK WHICH LED TO DESATURATION AND ASPHYXIA. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184220 AMARA FULL FACE MASK VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death