BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 100

    MDR report key: 16823212 · Received April 27, 2023

    Report

    Report Number
    3014660737-2023-53531
    Event Type
    Injury
    Date Received
    April 27, 2023
    Report Date
    April 27, 2023
    Manufacturer
    HERO HEALTH, INC.
    Product Code
    NXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE CONFIRMED CONCLUSIVELY, AS THE ISSUE COULD NOT BE REPRODUCED IN THE RETURNED DEVICE. THE DEVICE PASSED ALL FUNCTIONAL TESTS. 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 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

    ON 4/3 THE CAREGIVER REPORTED THAT THE HERO SMART DISPENSER KEPT MISMEDICATING THE PERSON THEY WERE TAKING CARE OF. THEY CONFIRMED THE UNIT DISPENSED TOO MANY MEDICATIONS AND THE USER WHO IS EPILEPTIC, HAS SEIZURES AND EARLY STAGES OF DEMENTIA, HAS CONSUMED THE EXTRA PILLS. THE USER ENDED UP IN THE EMERGENCY ROOM FOR 8 HOURS FOR OBSERVATIONS DUE TO EXTREMELY LOW HEART RATE. THE DEVICE LOGS WERE REVIEWED, AND THE CUSTOMER'S CLAIMS REGARDING THE UNIT DISPENSING EXTRA PILLS WERE NOT CONFIRMED.

    Description of Event or Problem · 0

    ON 4/3 THE CAREGIVER REPORTED THAT THE HERO SMART DISPENSER KEPT MIS-MEDICATING THE PERSON THEY WERE TAKING CARE OF. THEY CONFIRMED THE UNIT DISPENSED TOO MANY MEDICATIONS AND THE USER WHO IS EPILEPTIC, HAS SEIZURES AND EARLY STAGES OF DEMENTIA, HAS CONSUMED THE EXTRA PILLS. THE USER ENDED UP IN THE EMERGENCY ROOM FOR 8 HOURS FOR OBSERVATIONS DUE TO EXTREMELY LOW HEART RATE. THE DEVICE LOGS WERE REVIEWED, AND THE CUSTOMER'S CLAIMS REGARDING THE UNIT DISPENSING EXTRA PILLS WERE NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156255 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC. H100 H100-089311

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization