MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for HOVEROUND XHD manufactured by Hoveround Corporation.
[186133786]
The end user reported that while operating the power wheelchair at a high speed after taking a sleeping medication, the end user ran into a wall. Additionally, the end user was not wearing shoes or any type of foot coverings. Hoveround's owner's manual warns "[s]top using your power wheelchair immediately, and call for assistance if: you are taking medications, drugs, or alcohol that affect your ability to safely drive," and "[t]o avoid serious injury: always set the joystick/controller speed/response control to be consistent with the surrounding environment. In confined spaces and while learning to drive your power wheelchair, we recommend that the speed/response control be set to minimum," and "[t]o avoid serious injury or fatality from sudden unexpected movement of the chair or contact with moving parts and other objects: do not use your power wheelchair with bare feet. "
Patient Sequence No: 1, Text Type: N, H10
[186133787]
The end user was operating the power wheelchair while impaired on sleeping medication and ran into a wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056601-2020-00006 |
| MDR Report Key | 9903384 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-07-29 |
| Date Added to Maude | 2020-03-31 |
| 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 | MS. DEBRA SILVERS |
| Manufacturer Street | 2151 WHITFIELD INDUSTRIAL WAY |
| Manufacturer City | SARASOTA, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 8002436 |
| Manufacturer G1 | HOVEROUND CORPORATION |
| Manufacturer Street | 2151 WHITFIELD INDUSTRIAL WAY |
| Manufacturer City | SARASOTA, FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOVEROUND |
| Generic Name | MOTORIZED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-03-31 |
| Model Number | XHD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOVEROUND CORPORATION |
| Manufacturer Address | 2151 WHITFIELD INDUSTRIAL WAY SARASOTA, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-31 |