HERO 100
Report
- Report Number
- 3014660737-2023-48978
- Event Type
- Injury
- Date Received
- March 14, 2023
- Date of Event
- February 18, 2023
- Report Date
- March 14, 2023
- Manufacturer
- HERO HEALTH INC
- Product Code
- NXB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION FOUND OUT THA THE DEVICE WAS ABLE TO SUCCESSFULLY CONNECT TO THE NETWORK AND THE HERO CLOUD. NO FURTHER SEQUELA. 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 2/13 THE USER REPORTED NOT BEING ABLE TO CONNECT THEIR HERO SMART DEVICE TO WI-FI. THE MEMBER SUPPORT TEAM OBTAINED ADDITIONAL INFORMATION AND CONDUCTED TROUBLESHOOTING STEPS. THE USER CONFIRMED HAVING ACCESS TO THEIR MEDICATION. ON 2/18 THE USER REPORTED GOING TO THE EMERGENCY ROOM AND HAVING CHEST PAINS AND HEART PALPITATIONS. ON 2/19 THE USER ADDITIONALLY REPORTED HAVING INSOMNIA DUE TO NOT TAKING THE MEDICATION. THE USER AGAIN CONFIRMED THAT THEY WERE USING THE PILL ACCESS KEY AND TAKING THEIR MEDICATION AS INTENDED. THE USER REPORTED HAVING THYROID ISSUES. THE HERO SMART DISPENSER COULD NOT CONNECT TO USERS HOME NETWORK DUE TO A CHANGE WITH THEIR ROUTER CONFIGURATION. THE HERO SMART DISPENSER IS DESIGNED TO OPERATE WITHOUT AN INTERNET CONNECTION BY USING THE PILL ACCESS KEY. NO DEVICE ISSUE WAS REPORTED.
ON 2/13 THE USER REPORTED NOT BEING ABLE TO CONNECT THEIR HERO SMART DEVICE TO WI-FI. THE MEMBER SUPPORT TEAM OBTAINED ADDITIONAL INFORMATION AND CONDUCTED TROUBLESHOOTING STEPS. THE USER CONFIRMED HAVING ACCESS TO THEIR MEDICATION. ON 2/18 THE USER REPORTED GOING TO THE EMERGENCY ROOM AND HAVING CHEST PAINS AND HEART PALPITATIONS. ON 2/19 THE USER ADDITIONALLY REPORTED HAVING INSOMNIA DUE TO NOT TAKING THE MEDICATION. THE USER AGAIN CONFIRMED THAT THEY WERE USING THE PILL ACCESS KEY AND TAKING THEIR MEDICATION AS INTENDED. THE USER REPORTED HAVING THYROID ISSUES. THE HERO SMART DISPENSER COULD NOT CONNECT TO USERS HOME NETWORK DUE TO A CHANGE WITH THEIR ROUTER CONFIGURATION. THE HERO SMART DISPENSER IS DESIGNED TO OPERATE WITHOUT AN INTERNET CONNECTION BY USING THE PILL ACCESS KEY. NO DEVICE ISSUE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 914590 | HERO 100 | DISPENSER, SOLID MEDICATION | NXB | HERO HEALTH INC | H100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization | ESOMEPRAZOLEDR 40 MG| ESOMEPRAZOLEDR 40 MG| FAMOTIDINE 20 MG| FAMOTIDINE 20 MG| LEVOTHYROXINE SODIUM 25 MCG| LEVOTHYROXINE SODIUM 25 MCG |