MAUDE Adverse Event Report: HERO HEALTH INC HERO 100; PILL DISPENSER

Model Number	H100
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiovascular Insufficiency (4445)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 1/5 the user requested a replacement device due to automatic dispense failure and pill count issues.On 1/6 the user additionally reported that the device was notifying them that all the pills were dispensed, when they were not.Moreover, some of the medications were empty in the past due to the user not refilling the medications through the pharmacy, and after nearly two months not being able to get the medications they were hospitalized.The user also reported being taken to the emergency room with a heart failure, due to some of the medications being inside the device however out of the hero smart system schedule.They were unaware that these medications were not dispensed.
Additional Manufacturer Narrative
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.
Event or Problem Description
On 1/5 the user requested a replacement device due to automatic dispense failure and pill count issues.On 1/6 the user additionally reported that the device was notifying them that all the pills were dispensed, when they were not.Moreover, some of the medications were empty in the past due to the user not refilling the medications through the pharmacy, and after nearly two months not being able to get the medications they were hospitalized.The user also reported being taken to the emergency room with a heart failure, due to some of the medications being inside the device however out of the hero smart system schedule.They were unaware that these medications were not dispensed.

• Brand Name: HERO 100
• Common Device Name: PILL DISPENSER
• Manufacturer (Section D): HERO HEALTH INC; 85 broad street; new york NY 10004
• Manufacturer (Section G): HERO HEALTH INC; 85 broad street; new york NY 10004
• Manufacturer Contact: fred tobia ; 85 broad street; new york, NY 10004 ; 8558559962
• MDR Report Key: 16276816
• Report Number: 3014660737-2023-45868
• Device Sequence Number: 18508556
• Product Code: NXB
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: H100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LISINOPRIL 2.5 MG-UNABLE TO CONFIRM; LISINOPRIL 2.5 MG-UNABLE TO CONFIRM; SPIRONOLACTONE 25 MG-UNABLE TO CONFIRM; SPIRONOLACTONE 25 MG-UNABLE TO CONFIRM
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown