HERO 100
Report
- Report Number
- 3014660737-2023-53765
- Event Type
- Injury
- Date Received
- May 2, 2023
- Date of Event
- April 5, 2023
- Report Date
- May 2, 2023
- Manufacturer
- HERO HEALTH, INC
- Product Code
- NXB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
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.
THE USER HAS A SERIOUS CHRONIC CONDITION. NO ISSUE WAS FOUND IN THE RETURNED DEVICE. THE DEVICE PASSED ALL FUNCTIONAL TESTS AND THERE WAS NO WIFI/NETWORK PROBLEM WITH THE UNIT ON THE ELECTROMECHANICAL SIDE. THE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE CONFIRMED CONCLUSIVELY, AS THE ISSUE COULD NOT BE REPRODUCED IN THE RETURNED DEVICE. 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.
ON 4/5 THE USER REPORTED NOT BEING ABLE TO USE THE DEVICE FOR THREE MONTHS DUE TO WIFI ISSUES WITH THE HERO DISPENSER. THEY ALSO MENTIONED BEING BEHIND WITH THEIR MEDICATIONS AND BEING OFF WITH ONE FOR 3 WEEKS WHICH LED TO HOSPITALIZATION. THEY MENTIONED BEING UNAWARE OF BEING SHORT ON MEDICATIONS. THEY WERE ADMITTED FOR 3 DAYS.
ON 4/5 THE USER REPORTED NOT BEING ABLE TO USE THE DEVICE FOR THREE MONTHS DUE TO WIFI ISSUES WITH THE HERO DISPENSER. THEY ALSO MENTIONED BEING BEHIND WITH THEIR MEDICATIONS AND BEING OFF WITH ONE FOR 3 WEEKS WHICH LED TO HOSPITALIZATION. THEY MENTIONED BEING UNAWARE OF BEING SHORT ON MEDICATIONS. THEY WERE ADMITTED FOR 3 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161383 | HERO 100 | DISPENSER, SOLID MEDICATION | NXB | HERO HEALTH, INC | H100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |