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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISPORT, LLC 2GX WHEELCHAIR

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TISPORT, LLC 2GX WHEELCHAIR Back to Search Results
Model Number 2GX
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Bone Fracture(s) (1870)
Event Date 07/17/2018
Event Type  Injury  
Manufacturer Narrative

We reviewed the dhr for this chair, and it passed all applicable quality tests and configuration requirements, and met specifications as ordered by the dealer when it left the facility. The dealer and/or a therapist measure the user for a wheelchair. Tisport as the manufacturer builds the chair based on the measurements provided to us from the dealer and/or therapist. In this case, the dealer and/or therapist specified a chair that had a 1 inch shorter frame than the previous frame the end user was accustomed to, and did not accommodate for design differences between the series 1 and series 2 2gx to produce a chair with the same footprint.

 
Event Description

As described by the area sales manager, the customer's wheelchair allegedly tipped forward causing her to fracture her leg. We have not been provided any additional information about the injury, other than these allegations, at this time.

 
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Brand Name2GX
Type of DeviceWHEELCHAIR
Manufacturer (Section D)
TISPORT, LLC
2701 w court st
pasco WA 99301
Manufacturer Contact
briand english
2701 w court st
pasco, WA 99301
5095866117
MDR Report Key7791497
MDR Text Key117420082
Report Number3032618-2018-00003
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 08/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number2GX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/11/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/16/2018 Patient Sequence Number: 1
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