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

Model Number 2GX

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 12/12/2018

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.

Event Description

As described by the dealer, the customer's wheelchair allegedly tipped forward causing them to fracture their 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: brian english ; 2701 w court st; pasco, WA 99301 ; 5095866117
• MDR Report Key: 8237866
• MDR Text Key: 132764987
• Report Number: 3032618-2019-00001
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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: 12/12/2018
• 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