BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO100

    MDR report key: 17441679 · Received August 2, 2023

    Report

    Report Number
    3014660737-2023-62876
    Event Type
    Death
    Date Received
    August 2, 2023
    Date of Event
    January 3, 2023
    Report Date
    August 1, 2023
    Manufacturer
    HERO HEALTH, INC
    Product Code
    NXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS PROGRAMMED BY THE USER AND WAS OPERATING AS EXPECTED, PER DEVICE LOGS HISTORY REVIEW. NO DEVICE PROBLEM FOUND. THE HERO DEVICE SHOULD NOT BE USED BY A RECIPIENT OF MEDICATION WHO IS INCAPABLE OF VERIFYING THE ACCURACY OF EACH DISPENSED DOSE (SUCH AS THOSE SUFFERING FROM DEMENTIA OR OTHER COGNITIVE OR PHYSICAL IMPAIRMENTS) UNLESS PILL DISPENSE ACCURACY IS BEING VERIFIED, IN EACH INSTANCE, BY QUALIFIED PERSON(S) TRUSTED BY THE MEDICATION RECIPIENT, I.E. A CAREGIVER, A HEALTHCARE AIDE, AND/OR A HEALTHCARE PROFESSIONAL. THE MEDICATION RECIPIENT (OR A TRUSTED QUALIFIED PERSON) MUST ALWAYS VERIFY THAT THE TYPES OF PILLS AND NUMBER OF PILLS DISPENSED BY THE HERO DEVICE MATCH THE PRESCRIBED OR DESIRED DOSAGE BEFORE INGESTING THE CONTENTS OF THE PILL CUP. THE HERO DEVICE SHOULD NOT BE USED TO DISPENSE MEDICINES THAT HAVE HIGH DOSAGE SENSITIVITY, THAT HAVE A NARROW THERAPEUTIC WINDOW, THAT ARE USED TO TREAT ACUTE CONDITIONS OR THAT ARE USED TO TREAT LIFE-THREATENING EVENTS. EVEN THOUGH THE HERO DEVICE IS CAPABLE OF SUCCESSFULLY AND ACCURATELY DISPENSING MOST WHOLE PILLS LOADED INTO THE DEVICE ON MOST OCCASIONS, HERO CANNOT GUARANTEE THE ACCURACY OF MEDICATION DISPENSED DURING EVERY DISPENSE CYCLE DUE TO THE POTENTIAL FOR HUMAN ERROR AND/OR MECHANICAL AND SOFTWARE LIMITATIONS OR FAILURES.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS PROGRAMMED BY THE USER AND WAS OPERATING AS EXPECTED, PER DEVICE LOGS HISTORY REVIEW. NO DEVICE PROBLEM FOUND. THE HERO DEVICE SHOULD NOT BE USED BY A RECIPIENT OF MEDICATION WHO IS INCAPABLE OF VERIFYING THE ACCURACY OF EACH DISPENSED DOSE (SUCH AS THOSE SUFFERING FROM DEMENTIA OR OTHER COGNITIVE OR PHYSICAL IMPAIRMENTS) UNLESS PILL DISPENSE ACCURACY IS BEING VERIFIED, IN EACH INSTANCE, BY QUALIFIED PERSON(S) TRUSTED BY THE MEDICATION RECIPIENT, I.E. A CAREGIVER, A HEALTHCARE AIDE, AND/OR A HEALTHCARE PROFESSIONAL. THE MEDICATION RECIPIENT (OR A TRUSTED QUALIFIED PERSON) MUST ALWAYS VERIFY THAT THE TYPES OF PILLS AND NUMBER OF PILLS DISPENSED BY THE HERO DEVICE MATCH THE PRESCRIBED OR DESIRED DOSAGE BEFORE INGESTING THE CONTENTS OF THE PILL CUP. THE HERO DEVICE SHOULD NOT BE USED TO DISPENSE MEDICINES THAT HAVE HIGH DOSAGE SENSITIVITY, THAT HAVE A NARROW THERAPEUTIC WINDOW, THAT ARE USED TO TREAT ACUTE CONDITIONS OR THAT ARE USED TO TREAT LIFE-THREATENING EVENTS. EVEN THOUGH THE HERO DEVICE IS CAPABLE OF SUCCESSFULLY AND ACCURATELY DISPENSING MOST WHOLE PILLS LOADED INTO THE DEVICE ON MOST OCCASIONS, HERO CANNOT GUARANTEE THE ACCURACY OF MEDICATION DISPENSED DURING EVERY DISPENSE CYCLE DUE TO THE POTENTIAL FOR HUMAN ERROR AND/OR MECHANICAL AND SOFTWARE LIMITATIONS OR FAILURES. RETURN OF THE DEVICE WAS REQUESTED HOWEVER THE CUSTOMER FAILED TO RETURN IT AFTER MULTIPLE REQUESTS. AS A RESULT, NO PHYSICAL EVALUATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, HERO HEALTH HAS BEEN NOTIFIED THROUGH A THIRD PARTY THAT A USER DISPENSED 4 UNSCHEDULED PILLS. A PERSON INFORMED HERO HEALTH THAT THE USER PASSED AWAY. NO FURTHER INFORMATION WAS PROVIDED RAGRDING THE ADVERSE EVENT. AFTER INVESTIGATING THE DEVICE LOGS HERO ENGINEERS WERE UNABLE TO IDENTIFY ANY DEVICE MALFUNCTION AND THE UNIT WAS OPERATING AS PROGRAMMED BY THE END USER.

    Description of Event or Problem · 0

    ON 7/20/2023 HERO HEALTH HAS BEEN NOTIFIED THROUGH A THIRD PARTY THAT A USER DISPENSED (B)(4)UNSCHEDULED PILLS. A PERSON INFORMED HERO HEALTH THAT THE USER PASSED AWAY. NO FURTHER INFORMATION WAS PROVIDED RAGRDING THE ADVERSE EVENT. AFTER INVESTIGATING THE DEVICE LOGS HERO ENGINEERS WERE UNABLE TO IDENTIFY ANY DEVICE MALFUNCTION AND THE UNIT WAS OPERATING AS PROGRAMMED BY THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384986 HERO100 DISPESNER, SOLID MEDICATION NXB HERO HEALTH, INC H100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death OXYCODONE HCI 5MG.| OXYCODONE HCI 5MG.