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Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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Ge healthcare as investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.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 during a case, the patient had to be resuscitated.At the time of resuscitation, co2 had disappeared and halothane appeared on the device display.The patient recovered.
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Manufacturer Narrative
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A ge healthcare service representative performed a checkout of the aisys anesthesia device and the gas module and did not identify any issue with either device.Ge healthcare product engineering performed an investigation of this event.Per information in the complaint, the hospital staff confirmed the aisys anesthesia device never lost ventilation.The patient had to be resuscitated.The hospital staff declined to provide any additional information.As such, the date and time of the case could not be determined.The system logs were reviewed.There were occurrences of a loss of co2, however, it was not possible to determine which occurrences related to the event because the hospital did not disclose the date and time.The logs do not indicate any device malfunction that would align with missing co2 displayed values.Review of complaint data indicates no malfunction of the aisys anesthesia device or the gas module.The root cause of the of the loss of co2 and the patient resuscitation is undetermined.Based on the investigation, these devices did not cause or contribute to the adverse event.
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Search Alerts/Recalls
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