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 Z manufactured by Tisport, Llc.
[118552326]
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
[118552327]
The provider claims the therapist tested the anti-tips before getting the patient in, and as a result of the test the anti-tip tubes bent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032618-2018-00006 |
| MDR Report Key | 7820455 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-14 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2018-04-27 |
| 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 Z |
| Generic Name | WHEELCHAIR ANTI-TIP |
| Product Code | IMR |
| Date Received | 2018-08-27 |
| Returned To Mfg | 2018-08-27 |
| Model Number | AERO Z |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |