BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO 100

    MDR report key: 17622943 · Received August 25, 2023

    Report

    Report Number
    3014660737-2023-63658
    Event Type
    Death
    Date Received
    August 25, 2023
    Report Date
    August 25, 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

    A DEVICE MALFUNCTION ASSOCIATED WITH THIS CLINICAL RESULT CANNOT BE FOUND. IT APPEARS THAT THE USER MANUALLY TOOK MORE MEDICATIONS THAN NECESSARY. PER THE HERO DEVICE INSTRUCTION MANUAL "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

    A DEVICE MALFUNCTION ASSOCIATED WITH THIS CLINICAL RESULT CANNOT BE FOUND. IT APPEARS THAT THE USER MANUALLY TOOK MORE MEDICATIONS THAN NECESSARY. PER THE HERO DEVICE INSTRUCTION MANUAL " 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."

    Description of Event or Problem · 0

    PER THE CAREGIVER'S REPORT ON 8/03/2023, THE END USER HAD PASSED AWAY DUE TO OVERDOSING ON MEDICATIONS. THE CAREGIVER ALSO INDICATED THAT THE END USER HAD A SUBSTANCE ABUSE PROBLEM, AND USED THE PILL ACCESS KEY TO OBTAIN THE MEDICATION MANUALLY FROM THE DEVICE. A NEW PILL ACCESS KEY WAS REQUESTED TO BE SENT ON 3/10/2023, AND THE CUSTOMER CONFIRMED THAT THEY RECEIVED IT ON 3/14/2023. THE PILL ACCESS KEY IS REQUIRED IN THE CASE A USER CANNOT OBTAIN THEIR MEDICATIONS AS PER HERO DEVICE DEIGN. NOTIFICATIONS ARE BEING SENT TO THE CAREGIVER ADMIN ONCE THE DOOR IS OPENED WITH THE PILL ACCESS KEY. THE CAUSE OF DEATH COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    PER THE CAREGIVER'S REPORT ON 8/03/2023, THE END USER HAD PASSED AWAY DUE TO OVERDOSING ON MEDICATIONS. THE CAREGIVER ALSO INDICATED THAT THE END USER HAD A SUBSTANCE ABUSE PROBLEM, AND USED THE PILL ACESS KEY TO OBTAIN THE MEDICATION MANUALLY FROM THE DEVICE. A NEW PILL ACCESS KEY WAS REQUESTED TO BE SENT ON 3/10/2023, AND THE CUSTOMER CONFIRMED THAT THEY RECEIVED IT ON 3/14/2023. THE PILL ACCESS KEY IS REQUIRED IN THE CASE A USER CANNOT OBTAIN THEIR MEDICATIONS AS PER HERO DEVICE DEIGN. NOTIFICATIONS ARE BEING SENT TO THE CAREGIVER ADMIN ONCE THE DOOR IS OPENED WITH THE PILL ACCESS KEY. THE CAUSE OF DEATH COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283444 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC. H100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death