MAUDE Adverse Event Report: TISPORT, LLC 2GX; WHEELCHAIR

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.

• Brand Name: 2GX
• Type of Device: WHEELCHAIR
• 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 Key: 7791497
• MDR Text Key: 117420082
• Report Number: 3032618-2018-00003
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2GX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2018
• 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): Hospitalization