The information obtained reveals that the customer is using an outdated version of the hemo application, and the issue experienced has been addressed in later releases ((b)(4)).While it is the choice of the customer to remain on an older version, merge healthcare has recommended that customers upgrade to newer versions so that instances like these can be avoided.
|
Merge hemo monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the 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 hemo monitor pc via the serial interface.All data can be shown and monitored on the hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the hemo application "crashed" in the middle of an active case and an "unhandled exception" message was displayed.Information obtained from the customer indicated that the case had to be stopped and the patient was removed from the room while the problem was diagnosed.The system was eventually restarted and the case resumed; however the patient's monitoring data was lost.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.However, it was reported that the procedure was completed successfully once the application was rebooted.(b)(4).
|