It was found during troubleshooting efforts that the customer's reported problem affected two (2) related sites because they share the same server.However, the procedures in progress prior to this issue were not affected.The hemo users could not open or create a new study, so the site decided to cancel the remaining scheduled/elective procedures and activate their stemi divert plan.Only one (1) procedure was directly affected by this issue and the procedure was completed successfully.An internal investigation is underway (hemo-11038) and it was determined that the cause of the problem occurred when a site hemo user made changes to the hemo system config that affected the procedure documentation/reporting templates component.Merge healthcare has corrected the customer's templates component so that future occurrences do not occur.To date, no other customers have been identified with this issue.Device labeling, hemo-5303 v9 user manual, addresses the potential for such an occurrence by statements such as, "caution: system config should be managed by trained support personnel or the site administrator." (b)(4).
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Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the merge hemodynamics hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the merge hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the merge hemodynamics hemo monitor pc.On august 29, 2017, a customer reported to merge healthcare that a critical error occurred on the client pc during a coronary stent placement procedure.Subsequently, the hemo monitor and client pc were both rebooted causing a loss of physiological monitoring and patient data capture.Information obtained from the customer revealed that upon reboot, the client pc did not function as intended but the hemo monitor was capturing the patient's invasive pressures.The medical staff employed manual charting of the invasive pressures during the procedure while a portable monitoring device was used to capture the patient's vitals.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the procedure was completed successfully through the combined use of merge hemo, a portable vitals monitor, and manual charting.(b)(4).
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