MAUDE Adverse Event Report: A & I DRIVE; TRANSPORT CHAIR

Model Number	TS19
Medical Device Problem Codes	Use of Device Problem (1670); Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a transport chair.The end-user sat in the transport chair.The brake was engaged; the device was locked.The device is meant to be pushed by an attendant.(b)(6) tried to turn the chair.It went backwards and flipped over.He hit his head on the pavement.He was transported to the hospital by ems.Further tests revealed a sprained shoulder.

• Brand Name: DRIVE
• Common Device Name: TRANSPORT CHAIR
• Manufacturer (Section D): A & I; lian du industry park; le liu town; shunde district, foshan cit ; CH
• MDR Report Key: 8471389
• Report Number: 2438477-2019-00017
• Device Sequence Number: 1575776
• Product Code: INM
• UDI-Device Identifier: 00822383241432
• UDI-Public: 822383241432
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/01/2019
• Report Date (Section F): 04/01/2019

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: TS19
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/20/2019
• Device Age: 13 MO
• Event Location: Other
• Date Report to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2019
• 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: 85 YR
• Patient Weight: 108
• Date Report Sent to FDA: 04/01/2019