MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-01-07 for AERO X manufactured by Tisport, Llc.
[174285092]
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.
Patient Sequence No: 1, Text Type: N, H10
[174285093]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032618-2020-00001 |
| MDR Report Key | 9560582 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2018-05-15 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN ENGLISH |
| Manufacturer Street | 2701 W COURT ST |
| Manufacturer City | PASCO WA 99301 |
| Manufacturer Country | US |
| Manufacturer Postal | 99301 |
| Manufacturer Phone | 5095866117 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AERO X |
| Generic Name | WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2020-01-07 |
| Model Number | AERO X |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TISPORT, LLC |
| Manufacturer Address | 2701 W COURT ST PASCO WA 99301 US 99301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-07 |