MAUDE Adverse Event Report: HOVEROUND CORPORATION HOVEROUND; MOTORIZED WHEELCHAIR

Model Number	XHD
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction suspected; the end user's daughter reported while the end user was sitting in the power wheelchair and was not wearing the seatbelt, the end user slid onto the floor.Hoveround's owner's manual warns "to 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: keep your seat belt fastened, and always use the seat belt.".
Event or Problem Description
While sitting stationary in the power wheelchair and not wearing a seat belt, the end user slid out onto the floor.

• Brand Name: HOVEROUND
• Common Device Name: MOTORIZED WHEELCHAIR
• Manufacturer (Section D): HOVEROUND CORPORATION; 2151 whitfiled industrial way; sarasota FL 34243 4047
• MDR Report Key: 8893778
• Report Number: 1056601-2019-00016
• Device Sequence Number: 18883357
• Product Code: ITI
• UDI-Device Identifier: 00859781000033
• UDI-Public: (01)00859781000033(11)190129
• 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): 08/14/2019

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: 7 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/14/2019
• 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: 89 YR
• Patient Weight: 150