MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number 50T-RESR-MAXX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Bruise/Contusion (1754)

Event Date 01/18/2018

Event Type  malfunction  

Event Description

On 23-jan-2018, motion concepts was notified by medbloc (motion concepts importer) that one of their dealer (bellevue healthcare) was notified of an incident that took place on (b)(6) 2018.The dealer reported that the end user pulled up to his desk and lifted the armrest and when released it dropped.The end user was off balance when the armrest dropped and fell forward and his forearm hit the adductor.The end user got a bruise on his forearm as a result of hitting the adductor.

• 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: 7247268
• MDR Text Key: 99208466
• Report Number: 9615350-2018-00001
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00754014710393
• UDI-Public: 00754014710393
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 50T-RESR-MAXX
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2017
• 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 Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 75