HERO100
Report
- Report Number
- 3014660737-2023-48123
- Event Type
- Injury
- Date Received
- February 24, 2023
- Date of Event
- February 3, 2023
- Report Date
- February 24, 2023
- Manufacturer
- HERO HEALTH, INC
- Product Code
- NXB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
PER THE HERO DEVICE INSTRUCTION MANUAL, 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.
PER THE HERO DEVICE INSTRUCTION MANUAL, 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 2/3 THE CAREGIVER REPORTED THAT THE HERO SMART DEVICE DISPENSED THE WRONG MEDICATIONS AND THE USER WAS TAKEN TO THE EMERGENCY ROOM. THEY ALSO CONFIRMED THAT THEY WERE NOT GIVING THE USER THE WRONG MEDICATIONS SINCE THEY WERE ABLE TO RECOGNIZE THE PILLS. THE DEVICE PROMPTED THE USER TO VERIFY THE DOSE PRIOR CONSUMPTION, AS INTENDED FOR DEVICE USE. THE USER MAY HAVE HAD A MEDICATION REACTION (POSSIBLY A STROKE, AS MENTIONED BY THE CAREGIVER). THE CAREGIVER WAS NOT CERTAIN WHAT THE CAUSE OF THE REPORTED HEALTH EVENT WAS.
ON 2/3 THE CAREGIVER REPORTED THAT THE HERO SMART DEVICE DISPENSED THE WRONG MEDICATIONS AND THE USER WAS TAKEN TO THE EMERGENCY ROOM. THEY ALSO CONFIRMED THAT THEY WERE NOT GIVING THE USER THE WRONG MEDICATIONS SINCE THEY WERE ABLE TO RECOGNIZE THE PILLS. THE DEVICE PROMPTED THE USER TO VERIFY THE DOSE PRIOR CONSUMPTION, AS INTENDED FOR DEVICE USE. THE USER MAY HAVE HAD A MEDICATION REACTION (POSSIBLY A STROKE, AS MENTIONED BY THE CAREGIVER). THE CAREGIVER WAS NOT CERTAIN WHAT THE CAUSE OF THE REPORTED HEALTH EVENT WAS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1948046 | HERO100 | SOLID MEDICATION DISPENSER | NXB | HERO HEALTH, INC | H100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization | THE USER ON MULTIPLE MEDICATIONS.| THE USER ON MULTIPLE MEDICATIONS. |