BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    HERO SMART DISPENSER

    MDR report key: 16203677 · Received January 19, 2023

    Report

    Report Number
    3014660737-0005-00001
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    December 7, 2022
    Report Date
    December 23, 2022
    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

    FURTHER FOLLOW UP WITH THE CAREGIVER CONFIRMED THAT THE PATIENT WAS ALIVE AND FEELING WELL AFTER THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THE CAREGIVER REACHED OUT DUE TO THE HERO SMART DISPENSER FAILING TO AUTOMATICALLY DISPENSE MEDICATIONS AND OPENING THE DOOR FOR A MANUAL PILL RETRIEVAL, AS DESIGNED. IT WAS ALSO REPORTED THAT THE PRIMARY USER HAS DEMENTIA AND TRIED TO TAKE TOO MANY PILLS WHEN THE DOOR OPENED FOR A MANUAL MEDICATION RETRIEVAL. ON 12/8 THE TECHNICAL SUPPORT TEAM REACHED OUT TO OBTAIN ADDITIONAL INFORMATION AND TROUBLESHOOT THE ISSUE. THE CAREGIVER ADDED THAT THE USER OVERDOSED ON ARIPIPRAZOLE WHICH LED TO HOSPITALIZATION FOR TWO DAYS. THE USER WASN'T RESPONSIVE, COULD NOT WALK OR TALK, HOWEVER THE USER WAS FEELING WELL AT THE TIME OF THE CALL WITH THE CAREGIVER. THE INVESTIGATION OF THE DEVICE LOGS REVEALED THAT THE UNIT WAS UNABLE TO AUTOMATICALLY DISPENSE, HOWEVER THE HERO SMART DISPENSER HAS BEEN OPERATING AS DESIGNED AND WAS OPENING THE DOOR FOR THE MANUAL RETREIVAL OF MEDICATION. PER THE HERO DEVICE INSTRUCTION MANUAL VERSION 2.5" 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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369702 HERO SMART DISPENSER SOLID MEDICATION DISPENSER NXB HERO HEALTH INC 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization ARIPRIPAZOLE 5MG