This medial device report is being submitted due to a recent fda inspection held at agfa's (b)(4) location.It was determined that 17 additional occurrences identified with the same event issue as described in mdr report , fda # 9616389-2013-00003, but at different sites, required reporting to document the additional occurrences.This report is for an 18th event in which the customer informed agfa on (b)(6) 2014, that the site had experienced their dx-d100 unit exhibiting erratic movement when driving the unit.The unit had backed up into someone visiting the hospital, but it did not harm this person.The customer also stated the unit was hard to get movement started, and once forward movement was started, it was difficult to adjust to a walking speed as the unit remained at full speed.The agfa cse adjusted the gauge voltages and the micro switch in the handlebar.The dx-d100 unit for this site is now working as expected.No harm was reported for this event.Agfa investigation was already underway for a reportable correction to the fda on may 15, 2013: fda reference # (b)(4).For the corrections, agfa implemented mandatory service bulletins in which all affected units were replaced with new firmware and new digital motion control boards.All other documentation for the dx-d100 reportable correction will be reported via fda (b)(4).
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