Model Number 3100A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Cusp Tear (2656)
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Event Date 07/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).At this time, carefusion has not received the suspect device/component from the customer for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.
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Event Description
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The customer reported that once the oscillation was started, the start/stop switch had to be pressed at least ten (10) times to switch off the oscillation.The reported issue occurred during the pre-use patient circuit calibration but is intermittent.There was no patient involvement in this reported event.
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Manufacturer Narrative
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Results of investigation: the carefusion failure analysis laboratory received the suspect component, a 3100a driver displacement indicator board, and evaluated the device.An evaluation of the component did not duplicate the reported issue.There were no failures detected.
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Search Alerts/Recalls
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