Catalog Number 0607687000 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 06/06/2014 |
Event Type
Injury
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Event Description
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It was reported that during a procedure the autoplex system was not mixing automatically, which caused a 20 minute delay in the procedure.It was reported that the patient received additional anesthesia as a result of the delay.The procedure was completed successfully utilizing back-up equipment.No adverse consequences were reported with this event.
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Manufacturer Narrative
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The device will not be returned as it was discarded by the user facility; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.
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Manufacturer Narrative
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Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
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Event Description
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It was reported that during a procedure the autoplex system was not mixing automatically, which caused a 20 minute delay in the procedure.It was reported that the patient received additional anesthesia as a result of the delay.The procedure was completed successfully utilizing back-up equipment.No adverse consequences were reported with this event.
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Search Alerts/Recalls
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