MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-RESR-MAXX
Medical Device Problem Code	Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(4) 2017, "bolt that holds arm broke" was reported to motion concepts by the dealer ((b)(4)).On (b)(4) 2017, upon request by the dealer, motion concepts sent out a replacement parts order consisting of a trc2536 cantilever armrest.Assembly instructions were provided by motion concepts with the parts orders to complete the installation of the replacement parts.From the end user report (email on (b)(4) 2017), it appears that only a portion of the cantilever armrest assembly was replaced by the dealer, not the complete replacement assembly that was shipped by motion concepts to the dealer on (b)(4) 2017.On (b)(4) 2017, the dealer was advised that motion concepts will be sending another replacement parts order and the complete armrest assembly must be installed as per the instructions provided with the order.
Event or Problem Description
On 09-nov-2017, motion concepts was notified by (b)(4) (motion concepts importer) that one of their dealer (b)(4) reported 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: 7095552
• Report Number: 9615350-2017-00007
• Device Sequence Number: 16439765
• Product Code: ITI
• UDI-Device Identifier: 00754014710065
• UDI-Public: 00754014710065
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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?: No
• Type of Report(Section G): Thirty-Day
• 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