Model Number 1006-9305-000 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Loss of consciousness (2418)
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Event Date 05/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.
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Event Description
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The hospital reported that the patient consciousness did not return post-procedure.Medical treatment was given.
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Manufacturer Narrative
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A ge healthcare service representative performed a checkout of the system and a review of the logs.The unit was found to be operating normally.Ge healthcare product engineering performed an investigation of this event.Analysis of the complaint and customer report found no evidence of a system malfunction.It has been confirmed that there was no direct allegation against the ge healthcare device.Based on the investigation analysis, there is no evidence of a malfunction or defect of this unit and no evidence that the device contributed to the patient's not regaining consciousness.Therefore, no additional corrective or preventive actions are planned.The root cause is undetermined.
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Search Alerts/Recalls
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