MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-RESR-MAXX
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(4) 2017, medbloc was notified by one of its dealer (b)(4) regarding the following incident: "the right chair arm fell again on constance.This time it left a 2.5x.5 abrasion and bruise.The arm was replaced as well as the m8 hex head bolt.However the leaf spring which holds the arm in upward position was not.When the bolt sheared the first time it bent and fatigued the spring so that no it makes no contact with the hex head bolt.It is bent away from the arm.The left arm is intact and works.In that case the bolt head locks under the spring in the upright position preventing this type of injury.This needs immediate remediation.Also there remains a clip spring missing on the back control wire cover".

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1-7; concord, ontario L4K3C 1; CA L4K3C1
• MDR Report Key: 7095006
• Report Number: 1319669-2017-00004
• Device Sequence Number: 1461082
• Product Code: ITI
• UDI-Device Identifier: 00754014710065
• UDI-Public: 00754014710065
• 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): 12/07/2017
• Report Date (Section F): 12/07/2017

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: No Information
• Device Model Number: 45T-12L-RESR-MAXX
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/08/2017
• Device Age: 6 MO
• Date Report to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2017
• 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: Other
• Patient Weight: 61
• Date Report Sent to FDA: 12/07/2017