MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-27 for AERO T manufactured by Tisport, Llc.
[118553271]
No injury was reported in this event. There is a risk of serious injury in the case of a failure of the anti-tips while engaged. The returned samples of the anti-tips were tested, along with samples from the then-current lot and of a different lot. The results of a combination of internal and external/third-party testing indicates that the material of the anti-tip tube used on the construction of this chair was softer and weaker than the design specified.
Patient Sequence No: 1, Text Type: N, H10
[118553272]
The provider claims that they were performing an anti-tip check that they do with every client by having the user lean back on the anti-tips to make sure the front casters are not more than 4" off the ground; this test is performed on a level surface. While they did this check, the tech noticed the anti-tip extensions were beginning to bend. The tech claims that before this test, he adjusted the center of gravity as far back as he could, and tried to change the position where the anti-tip was mounted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032618-2018-00005 |
| MDR Report Key | 7820451 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-07-31 |
| Date Added to Maude | 2018-08-27 |
| 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 T |
| Generic Name | WHEELCHAIR ANTI-TIP |
| Product Code | IMR |
| Date Received | 2018-08-27 |
| Model Number | AERO T |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-27 |