Carestream health has evaluated the device.The investigation found that there were no device malfunctions and the incident was caused by the user not following the instructions for use (ifu).The site contact confirmed that the tech was not positioned directly behind the unit to drive the revolution as specified in the ifu.There was no device malfunction.This was due to user error.The service personnel communicated to the operators to be positioned directly behind the unit, per the instructions for use (ifu), while driving the system.Carestream has completed this investigation.
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On (b)(6) 2022, carestream health (csh) was informed of an incident related to the drx-revolution mobile x-ray system which occurred at (b)(6), brazil on (b)(6) 2022.Per carestream health service personnel investigation which confirmed the following: the system in "as found" condition: found no abnormality in the driving cart.At the time of the incident, the system was being driven by a site tech.The technologist was reversing the system out of an elevator when the drx-revolution passed over the operator's toe.The incident resulted in a toe injury where the tech's toe was fractured.There was no patient involvement.
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