MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-09-21 for ZRA manufactured by Tisport, Llc.
[121458866]
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. It is unclear whether the user was reclined on the anti-tips, or propelling with the anti-tips being used as wheels instead of the front casters, which are not recommended by the owners manual, but the owners manual does recommend in chapter 1 section i: -2. Never use your chair on a slope greater than 10% -9 always lean or press your body in the uphill direction. This will help shift your weight to counteract the change in the center of balance caused by the hill, slope or ramp. The owners manual also warns in chapter 1 warnings section a -2. If your anti-tips are set too low, they may "catch" on obstacles that you can expect to encounter in normal wheelchair use. If this happens, you may tip over and fall. -4. Always keep your anti-tips locked in place in the "down" position unless: --a. You have an attendant (but your attendant must rotate the anti-tips into the "down" position whenever he or she leaves you unattended in your chair, even for a moment), or --b. You have to climb or descend a curb or step or overcome an obstacle. Even if this is the case, only unlock the anti-tips if you can safely climb or descend the curb or step or overcome the obstacle and make sure the anti-tips are locked in the "up" position a review of the dhr indicates that the wheelchair passed all applicable quality tests and configuration requirements, and met all specifications as ordered by the dealer when it left the facility. The anti-tip in question was requested to be returned, but has not yet been returned. We do not have any further information about the event, other than these allegations at this time. If more information is provided that changes the nature of the investigation, a follow up medwatch form 3500a will be filed.
Patient Sequence No: 1, Text Type: N, H10
[121458867]
Customer alleges that the anti-tip extension on a user friendly anti-tip broke during use. The end user was reportedly not injured. Anti-tips in question were ordered separately from the chair on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032618-2018-00009 |
| MDR Report Key | 7899903 |
| Report Source | USER FACILITY |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-08-24 |
| Device Manufacturer Date | 2018-01-29 |
| Date Added to Maude | 2018-09-21 |
| 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 | ZRA |
| Generic Name | WHEELCHAIR ANTI-TIP |
| Product Code | IMR |
| Date Received | 2018-09-21 |
| Model Number | ZRA |
| 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 | 2018-09-21 |