MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number	MPV5
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction discovered.The end user was not clear on what happened, however, it is most likely the incident occurred when the user attempted to exit the power wheelchair, stood on the footplate or leaned on the armrest and fell.Additionally, the end user was not wearing the seat belt at the time of the incident.Hoveround's owner's manual warns "to reduce the chance of serious injury or death from tip-over or falling from the power wheelchair, do not stand on footplate.Do not put weight on footplate, armrest or controller while getting into or out of the power wheelchair." and "[t]o reduce the chance of serious injury or death from tip-over, collision with obstacles, loss of control, or falling from the power wheelchair, keep yourself properly positioned in the seat: do not reach over the back of the chair or lean excessively forward or sideways.".
Event or Problem Description
The end user's daughter reports that while operating the power wheelchair in the bathroom the user lost control of the power wheelchair and fell.The end user was not using the seat belt.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 6015 31st street e; suite 201; bradenton FL 34203 5317
• Manufacturer (Section G): HOVEROUND CORPORATION; 2318 whitfield industrial way; sarasota FL 34243 4047
• MDR Report Key: 17043288
• Report Number: 1056601-2023-00004
• Device Sequence Number: 20960152
• Product Code: ITI
• UDI-Device Identifier: 00859781000019
• UDI-Public: (01)00859781000019(10)22/04/28(11)5871708
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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: MPV5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 102 KG