MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-10 for AERO Z manufactured by Tisport, Llc.
[144804855]
We reviewed the dhr for this chair, and it passed all applicable quality tests and configuration requirements, and met specifications as ordered by the dealer when it left the facility. The dealer and/or a therapist measure the user for a wheelchair. Tisport as the manufacturer builds the chair based on the measurements provided to us from the dealer and/or therapist. All documentation and specifications for the chair were appropriately disseminated to the health specialist working with the end user. The device was not returned for evaluation, but a company representative inspected the chair on site. The inspection revealed that the seat back angle had been increased by roughly 19 degrees, and the set length of the anti-tips had been reduced by an inch from the original specifications. By increasing the seat back angle, the chair holds the end user's weight further back, which increases the therapist of a backwards tip. With the anti-tip length reduced, the effectiveness of the anti-tips is compromised, allowing the chair to rotate over the anti-tips in a backward tip event. The wheelchair closet worker present at the time of the adverse event was consulted about the configuration concerns, and was shown how to adjust the anti-tip assemblies to their specified position. If more information is provided that changes the conclusions of the investigation, a follow up medwatch form 3500a will be filed.
Patient Sequence No: 1, Text Type: N, H10
[144804856]
Provider alleges the patient was attempting to propel a manual wheelchair during outpatient evaluation when the chair tipped back and the patient's head struck the ground. People nearby reported hearing the snap of bone, and the end user allegedly state he thought he broke his neck again. We have been in contact with the wheelchair closet sinse this incident, but we have not been provided any additional information about the injury, other than these allegations, at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032618-2019-00005 |
| MDR Report Key | 8601358 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-04-11 |
| Device Manufacturer Date | 2018-01-02 |
| Date Added to Maude | 2019-05-10 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AERO Z |
| Generic Name | WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2019-05-10 |
| Model Number | AERO Z |
| 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. Hospitalization | 2019-05-10 |