Model Number EU:1452442 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Rupture (2208)
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Event Date 03/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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This event occurred in (b)(6).Invacare is filing this report because the device is also marketed and sold in the u.S.The device and additional information about the event have been requested but no further details have been provided at this time.The cause of the issue could not be confirmed without the return of the device.Should additional information become available, a supplemental record will be filed.
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Event Description
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The right parking brake does not work correctly.The brake was blocked and the brake pad was loose.
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Manufacturer Narrative
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The device was returned to invacare europe.Their evaluation concluded: the brake system of the affected rollator was investigated, both brake system components were easy to turn in the rear frame tube.The investigation of the wheels showed that the bearings were worn which could lead to a wobbling effect of the rollator.The wobbling of the wheels combined with the turned brake pad, could possibly lead to a continuous small brake effect during movement.As the distance between the brake pad and the wheels is narrowed the force needed to engage the parking brake is higher than the user is accustomed.The most probable cause of the incident is that the parking brake was working but it wasn¿t fully engaged by the user which led to the movement of the rollator on the right site (the left side parking brake was fully engaged) causing the user to fall.
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Event Description
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The right parking brake does not work correctly.The brake was blocked and the brake pad was loose.
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Search Alerts/Recalls
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