MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for HOVEROUND MPV5 manufactured by Hoveround Corporation.
[188837214]
The end user reported while operating the power wheelchair up a ramp at the highest speed setting, the end user drove off the side of the ramp and fell. Hoveround's owner's manual warns "to 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. "
Patient Sequence No: 1, Text Type: N, H10
[188837215]
Sometime in (b)(6) 2019, the end user was operating the power wheelchair up a ramp on the fastest speed setting and drove off the side of the ramp and fell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056601-2020-00004 |
| MDR Report Key | 9687746 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2016-10-04 |
| Date Added to Maude | 2020-02-10 |
| 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 | 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 | 2020-02-10 |
| Model Number | MPV5 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 YR |
| 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 | 2020-02-10 |