It was reported by a customer in the usa that, during patient use, the 840 ventilator keyboard was unresponsive, with the graphical user interface (gui) key stuck.The patient was transferred to another ventilator.There was no reported patient injury.
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The covidien customer support engineer (cse) evaluated the device, and observed that the ventilator was soaked by a broken iv bag, which spilled all over the unit.There was no issues found with the unit, and no parts were replaced.The unit passed all tests and calibrations, and it was observed to be operating within manufacturing specifications.(b)(4).
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