An internal investigation conducted by merge healthcare found that if the hemo monitor pc is powered up and there is no active network connection, the hemo monitor pc will report an appropriate error to the event log, but currently will not attempt any retries to establish the connection to the hemo client pc.No active network connection can occur if the cable between the hemo monitor pc and hemo client pc is disconnected, or if the hemo client pc has not been powered up.Merge technical support found through remote access that the hemo monitor was left on all night but had lost connection to the client pc during this time resulting in a loss of communication between the two (2) devices.The hemo monitor did not reconnect to the client pc once it was on.Once the hemo monitor was rebooted, the connection was reestablished and communication worked properly.This problem has been addressed and will be corrected in a future version, merge hemo 10.2.It should be noted that the site has multiple cath labs onsite but the medical staff chose to remain in that lab and continue with the procedure.Merge healthcare documentation shows that the customer was notified of this issue on 29mar2016 (document id (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 (b)(6) 2016, a customer reported to merge healthcare that hemo physio controls were grayed out during a stemi (st elevation myocardial infarction) procedure caused by a communication failure between the hemo monitor and client pc.This results in the inability to capture and document patient vitals within the hemo client pc chronlog.When communication fails, patient vitals continue to be displayed on the hemo monitor pc except for non-invasive blood pressure (nibp) data.This required a reboot/restart of the hemo monitor pc which interrupts the ability to capture and document patient vitals.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that could result in harm to the patient.The customer reported that the procedure was completed through manual charting; however, full disclosure was not obtained due to the loss of communication between the hemo monitor and the client pc.(b)(4).
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