While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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The device was received, but was missing the air filter at the hose.Lack of water to the unit can cause inserts to heat up.The missing air filter is unlikely to cause hot inserts.Manufacturing was contacted regarding the missing air filter on the air line.Manufacturing evaluated the situation and determined that it is highly unlikely for the airline to have air filter missing when the unit was shipped out.Each air supply line gets assembled and tested per u-4304.It is possible that the air filter was not returned by the customer.Also, a dhr review was conducted with no discrepancies noted.
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