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 a 11th event in which a agfa field service engineer informed agfa on (b)(6) 2013, that due to a dealer in turkey stating one of their customer's dx-d100 unit was showing signs of unintended movement, the agfa engineer performed the dx-d100 latest version upgrade of the firmware, per a mandatory service bulletin by agfa, and checked the gauges, voltage and encoder connections.The end use customer information has not been provided and is unknown.The unit worked well for one day, but then stopped moving completely.Agfa determined there was a defective part for the digital motion control board; therefore, after working with sedecal, the vendor supplying the replacement parts, agfa replaced the digital motion control board, gauges and adjusted voltages with good parts.The dx-d100 unit for this site is now working as expected.No harm has been 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 to be 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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