MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for AERO T manufactured by Tisport, Llc.
[118552394]
The injuries reported in this case were not considered to be serious, however there is a risk of serious injury in the case of a failure of 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 in the construction of this chair was softer and weaker than the design specified.
Patient Sequence No: 1, Text Type: N, H10
[118552395]
The provider took the end user in their new wheelchair out to the parking lot of the hospital where the end user propelled themselves up a slight incline. Allegedly during this time, the chair rocked backwards and contacted the anti-tips three times, where on the third time the anti-tip tubes failed and the chair fell backwards. The provider claims that the end user hit his head and a ct was done, but that so far, he is okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032618-2018-00004 |
| MDR Report Key | 7820446 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-07-30 |
| Device Manufacturer Date | 2018-07-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| 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 |