MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number STRX-ULMXTRESR-50

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2018

Event Type  Injury  

Manufacturer Narrative

On 01-sep-2015, the system was shipped to the dealer ((b)(6)) according to the end user specification provided.(b)(6) stated that the end user system was involved in an automobile accident.The other driver drove into end user vehicle.There is no injury or device malfunction reported.However, system was involved in an automobile accident, so we consider it as a reportable.

Event Description

On (b)(4) 2019, motion concepts was informed by (b)(4) (motion concepts importer), that one of their dealer at (b)(6), was notified on an accident that took place on (b)(6) 2018.(b)(6) reported that the end user system was involved in an automobile accident.The other driver drove into end user vehicle and he needs to order parts to fix the system.System received damage to the casters, gear boxes, right and left motor and rear shocks.Fortunately, end user was not reported in any kind of injury.Dealer stated that the incident is not because of any system malfunction.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1-7; concord, ontario L4K3C 1; CA L4K3C1
• Manufacturer (Section G): MOTION CONCEPTS LP; 84 citation drive; unit 1-7; concord, ontario L4K3C 1; CA L4K3C1
• Manufacturer Contact: dona bhamra ; 84 citation drive; unit 1-7; concord, ontario L4K3C-1 ; CA L4K3C1
• MDR Report Key: 8551777
• MDR Text Key: 143242850
• Report Number: 9615350-2019-00002
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: STRX-ULMXTRESR-50
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 84