MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-26 for AERO X manufactured by Tisport, Llc.
[188837198]
The dhr for this chair was reviewed and the chair passed all applicable quality tests and configuration requirements. It met all specifications when it left the facility. Limited information was provided by the customer regarding the exact nature of the alleged incident. A letter from the user's attorney stated that the user "fell backwards" and sustained injuries. After follow up with the attorney, we were told the user sustained minor head injuries and a broken rib. The user had received a demo chair that was not configured specifically for him, he was an amputee and the chair was not equipped with an amputee axle plate. However, the chair had been equipped with anti-tips prior to him taking possession. There is not enough information about the incident to understand any contributing factors. We have not been provided any additional information about the event. A follow up medwatch form 3500a will be submitted if any additional information is provided.
Patient Sequence No: 1, Text Type: N, H10
[188837199]
While in use of a tilite wheelchair, a user had a backwards fall and sustained minor head injuries and a broken rib.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032618-2020-00003 |
| MDR Report Key | 9757502 |
| Report Source | CONSUMER |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2014-09-09 |
| Date Added to Maude | 2020-02-26 |
| 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 | FRED ORTMANN |
| Manufacturer Street | 2701 W COURT ST |
| Manufacturer City | PASCO, WA |
| Manufacturer Country | US |
| Manufacturer Phone | 5866117 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AERO X |
| Generic Name | WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2020-02-26 |
| Model Number | AERO X |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 5 YR |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-26 |