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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM
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MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM Back to Search Results
Model Number 50T-MAXX
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/21/2018
Type of Reportable Event Serious Injury
Event or Problem Description
On may-09-2018, medbloc was notified by one of its dealers in (b)(4) about an incident that took place on (b)(6) 2018.The dealer reported that the system was hit by a car while crossing the road and they needed parts for replacement.Fortunately, it does not sound she was injured.Dealer stated that he needed the front rigging and arm pads for replacement and the incident is not because of any system malfunction.
 
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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 Key7540876
Report Number1319669-2018-00003
Device Sequence Number18871774
Product Code ITI
UDI-Device Identifier00754014710362
UDI-Public00754014710362
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/24/2018
Report Date (Section F) 05/24/2018
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 Number50T-MAXX
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/09/2018
Device Age10 MO
Date Report to Manufacturer05/09/2018
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Weight94
Date Report Sent to FDA05/24/2018
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