MAUDE Adverse Event Report: TISPORT, LLC AERO X; WHEELCHAIR

Model Number AERO X

Device Problem Use of Device Problem (1670)

Patient Problem Tooth Fracture (2428)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

We reviewed the dhr for this chair, and it passed all applicable quality tests and configuration requirements, and met all specifications as ordered when it left the facility.The alleged event occured on a sidewalk that was described as being "very uneven with holes," and the event itself was described as being the result of the caster becoming stuck in a hole.An after market power adaptor was described as being installed; it is unclear if the power adapter was in use at the time of the incident, but by using a power adaptor, the speed and response of the end user leading up to the incident could have impacted the likelyhood of a user mistake and subsequent failure.We provide many warnings and guidances in the owners manual, including the following: chapter 1: warnings - section h.Terrain: your tilite wheelchair is designed for riding over firm, relatively smooth surfaces such as concrete and asphalt outdoors and indoor flooring (wood, tile, etc.) and carpeting.Your tilite wheelchair is not designed for riding oversand, loose soil or rough terrain.Do not operate your chair in such terrain.You may damage the wheels or axles or loosen fasteners of your chair.If you ignore these warnings, you may fall, tip over or lose control of the wheelchair and seriously injure yourself or others or damage the wheelchair.Section g.Obstacles: warning: when riding outdoors, uneven pavement, sidewalk irregularities, potholes and other obstacles and road hazards can be dangerous.When riding indoors, doorway thresholds, plush carpeting and other obstacles can be dangerous.In order to avoid these risks: 1.Always be alert for such dangers.2.Always scan the area ahead of you as you ride.If you ignore these warnings, you may fall, tip over or lose control of the wheelchair and seriously injure yourself or others or damage the wheelchair.Section i.Hills/slopes/ramps: warning: the center of balance of your chair is affected by the slope of the surface over which you are riding.Because your center of balance will be affected, your chair will be less stable when it is at an angle.This is especially true when riding on a slope sideways.Furthermore, do not assume anti-tips will prevent a fall or tip-over under these conditions.We have not been provided any addition information about the event or the condition of the customer at this time.A follow up medwatch form 3500a will be submitted if any additional information is provided.

Event Description

The end user's mother alleges that while the patient was on an uneven sidewalk with holes, the caster contacted and became stuck in a hole and a bolt in the fork assembly broke, causing the patient to fall forward and break her teeth.

• Brand Name: AERO X
• 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: 9560582
• MDR Text Key: 174285092
• Report Number: 3032618-2020-00001
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K072311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AERO X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• 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): Required Intervention