MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number	XHD
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end user reported that while operating the power wheelchair at a high speed after taking a sleeping medication, the end user ran into a wall.Additionally, the end user was not wearing shoes or any type of foot coverings.Hoveround's owner's manual warns "[s]top using your power wheelchair immediately, and call for assistance if: you are taking medications, drugs, or alcohol that affect your ability to safely drive," and "[t]o avoid serious injury: always set the joystick/controller speed/response control to be consistent with the surrounding environment.In confined spaces and while learning to drive your power wheelchair, we recommend that the speed/response control be set to minimum," and "[t]o avoid serious injury or fatality from sudden unexpected movement of the chair or contact with moving parts and other objects: do not use your power wheelchair with bare feet.".
Event or Problem Description
The end user was operating the power wheelchair while impaired on sleeping medication and ran into a wall.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 2151 whitfield industrial way; sarasota, fl
• MDR Report Key: 9903384
• Report Number: 1056601-2020-00006
• Device Sequence Number: 19512511
• Product Code: ITI
• UDI-Device Identifier: 00859781000033
• UDI-Public: (01)00859781000033(11)190729
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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: XHD
• Was Device Available for Evaluation?: No
• Device Age: 8 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Weight: 142