Mobius Mobility LLC 22007 ユーザーズマニュアル
IBOT 4000 ADVERSE
EVENTS REPORTED
EVENTS REPORTED
A review of the FDA’s MAUDE database was
performed and the following device-related
adverse events were reported for the iBOT 4000
Mobility System:
performed and the following device-related
adverse events were reported for the iBOT 4000
Mobility System:
Known Use
Problem
Description
Improper
stair
climbing
technique
stair
climbing
technique
Multiple users reported
improper stair climbing
technique leading to a fall.
improper stair climbing
technique leading to a fall.
Loss of
traction
traction
Multiple users reported a loss
of traction either in balance
mode or while attempting curbs
leading to a fall.
of traction either in balance
mode or while attempting curbs
leading to a fall.
Table 2:
Adverse Events Report
Known Use
Problem
Description
Inadequate
space for
transition
space for
transition
Multiple users reported
performing a transition in
limited space and the device
getting caught on the
environment leading to a fall.
performing a transition in
limited space and the device
getting caught on the
environment leading to a fall.
Drove into
object
object
Users have reported driving into
or over objects like a bike or a
stack of bricks leading to a fall.
or over objects like a bike or a
stack of bricks leading to a fall.
Sudden CG
shift
shift
Users reported a sudden
change in center of gravity
(trying to catch a falling object)
leading to an auto transition on
an object and a subsequent fall.
change in center of gravity
(trying to catch a falling object)
leading to an auto transition on
an object and a subsequent fall.
Stuck
joystick
joystick
Users have reported a stuck
joystick leading to driving into
an object.
joystick leading to driving into
an object.
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DKPX-09006-001-Rev. 1.7