HOVEROUND MPV5

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number1056601-2020-00004
MDR Report Key9687746
Date Received2020-02-10
Date of Report2020-02-10
Date of Event2019-05-01
Date Mfgr Received2020-02-05
Device Manufacturer Date2016-10-04
Date Added to Maude2020-02-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DEBRA SILVERS
Manufacturer Street2151 WHITFIELD INDUSTRIAL WAY
Manufacturer CitySARASOTA, FL
Manufacturer CountryUS
Manufacturer Phone8002436
Manufacturer G1HOVEROUND CORPORATION
Manufacturer Street2151 WHITFIELD INDUSTRIAL WAY
Manufacturer CitySARASOTA, FL
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHOVEROUND
Generic NameMOTORIZED WHEELCHAIR
Product CodeITI
Date Received2020-02-10
Model NumberMPV5
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age4 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOVEROUND CORPORATION
Manufacturer Address2151 WHITFIELD INDUSTRIAL WAY SARASOTA, FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-02-10

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