MAUDE Adverse Event Report: UNKNOWN DRIVE; POWER CHAIR

Model Number	TITAN18CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a power chair.The wheels had been catching on carpet and uneven terrain causing occupant to be thrown.The end-user was going down a ramp backwards.The device flipped forwards.The end-user sustained a broken tibia in his left leg.Product includes a safety belt.

• Brand Name: DRIVE
• Common Device Name: POWER CHAIR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8488536
• Report Number: 2438477-2019-00018
• Device Sequence Number: 14121195
• Product Code: ITI
• UDI-Device Identifier: 00822383513331
• UDI-Public: 822383513331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2019
• Report Date (Section F): 04/05/2019

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: TITAN18CS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/05/2019
• Device Age: 3 MO
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2019
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 68
• Date Report Sent to FDA: 04/05/2019