HERO100
Report
- Report Number
- 3014660737-2023-48671
- Event Type
- Injury
- Date Received
- March 7, 2023
- Date of Event
- February 8, 2023
- Report Date
- March 2, 2023
- Manufacturer
- HERO HEALTH, INC
- Product Code
- NXB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
THE DEVICE WAS ABLE TO DISPENSE PILLS EVEN WITH LIGHT FILTER CLOG ON THE VACUUM/PRESSURE SYSTEM, AND THE DEVICE PASSED ALL THE FUNCTIONAL TESTS. HOWEVER, THE UNIT SUFFERED FROM SHIPPING DAMAGE, SO THE TESTS ARE NOT A TRUE REPRESENTATION OF THE DEVICE PERFORMANCE IN THE FIELD AND UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. 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 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 2/08 THE USER REPORTED DISPENSE ISSUES. THE HERO SMART DISPENSER DISPENSED MULTIPLE EXTRA PILLS. THE CUSTOMER CONSUMED THE EXTRA PILLS, THEY WERE NOT FEELING WELL AND ENDED UP IN THE HOSPITAL. WE REACHED OUT TO THE CUSTOMER THREE TIMES TO FIND OUT THE REASON FOR HOSPITALIZATION AND THERE WAS NO RESPONSE.
ON 2/08 THE USER REPORTED DISPENSE ISSUES. THE HERO SMART DISPENSER DISPENSED MULTIPLE EXTRA PILLS. THE CUSTOMER CONSUMED THE EXTRA PILLS, THEY WERE NOT FEELING WELL AND ENDED UP IN THE HOSPITAL. WE REACHED OUT TO THE CUSTOMER THREE TIMES TO FIND OUT THE REASON FOR HOSPITALIZATION AND THERE WAS NO RESPONSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736482 | HERO100 | DISPENSER, SOLID MEDICATION | NXB | HERO HEALTH, INC | H100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |