BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 100

    MDR report key: 20863546 · Received December 6, 2024

    Report

    Report Number
    3014660737-2024-89650
    Event Type
    Injury
    Date Received
    December 6, 2024
    Report Date
    November 11, 2024
    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

    AS PER DESIGN, THE HERO SMART DISPENSER IS PROGRAMMED TO RECOGNIZE THE AUTOMATIC DISPENSE FAILURE AND PROMPTS FOR A MANUAL RETRIEVAL OF THE FAILED MEDICATION. THE USER SHOULD FIRST PRESS THE CENTER BUTTON TO CONFIRM THE FAILED MEDICATION AND AFTER THE BUTTON IS PRESSED THE UNIT OPENS THE DOOR FOR A MANUAL RETRIEVAL OF THE PILLS. THE DEVICE PREFORMED AS DESIGNED. 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

    AS PER DESIGN, THE HERO SMART DISPENSER IS PROGRAMMED TO RECOGNIZE THE AUTOMATIC DISPENSE FAILURE AND PROMPTS FOR A MANUAL RETRIEVAL OF THE FAILED MEDICATION. THE USER SHOULD FIRST PRESS THE CENTER BUTTON TO CONFIRM THE FAILED MEDICATION AND AFTER THE BUTTON IS PRESSED THE UNIT OPENS THE DOOR FOR A MANUAL RETRIEVAL OF THE PILLS. THE DEVICE PREFORMED AS DESIGNED. AFTER THE PHYSICAL EVALUATION OF THE DEVICE IT HAS BEEN CONFIRMED THAT THE ROOT CAUSE OF THE REPORTED EVENT IS NIB INVERSION, OR THE COLLAPSE/FOLDING IN OF THE PLEATED SECTION OF THE NIB. 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 (B)(6) 2024 THE CUSTOMER REPORTED THAT THEY ENDED UP IN THE ER/HOSPITAL FOR THREE DAYS DUE TO TAKING THEIR MEDICATION BY HAND INCORECTLY. THE CUSTOMER CONFIRMED THAT SOMETIMES WHEN THE DEVICE PROMPTS MANUAL RETRIEVAL OF PILLS, THE NAME OF THE MEDICATION DOES NOT MATCH THE PILL IN THE MEDICATION CARTRIDGE. THE REPORTED ISSUE COULD BE A RESULT OF A USER CONFUSION WITH MIXING MEDICATION CARTRDIGES. IT IS NOT CLEAR FROM THE CUSTOMER'S REPORT IF THE CARTRIDGES WERE LOADED WITH THE CORRECT MEDICATION SINCE THEY CONFIRMED THEY COULD RECOGNIZE THE PILLS IN THE PROCESS OF MANUAL RETRIEVAL OF THE MEDICAITON.

    Description of Event or Problem · 0

    ON 11/11/2024 THE CUSTOMER REPORTED THAT THEY ENDED UP IN THE ER/HOSPITAL FOR THREE DAYS DUE TO TAKING THEIR MEDICATION BY HAND INCORRECTLY. THE CUSTOMER CONFIRMED THAT SOMETIMES WHEN THE DEVICE PROMPTS MANUAL RETRIEVAL OF PILLS, THE NAME OF THE MEDICATION DOES NOT MATCH THE PILL IN THE MEDICATION CARTRIDGE. THE REPORTED ISSUE COULD BE A RESULT OF A USER CONFUSION WITH MIXING MEDICATION CARTRIDGES. IT IS NOT CLEAR FROM THE CUSTOMER'S REPORT IF THE CARTRIDGES WERE LOADED WITH THE CORRECT MEDICATION SINCE THEY CONFIRMED THEY COULD RECOGNIZE THE PILLS IN THE PROCESS OF MANUAL RETRIEVAL OF THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095433 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC. H100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization