Information obtained from the customer revealed that the site has called in to merge technical support on two (2) other occasions reporting a similar issue.These events have also met the criteria as a reportable event and have been captured in initial mdr reports #2183926-2017-00185 and #2183926-2017-00187.For this occurrence, during the time the hemo monitor rebooted the pdm (patient data module) buzzed indicating a connection loss.It was determined that the hemo monitor had a bad hard drive, so merge technical support shipped the customer a replacement hard drive (rma #13126).The faulty hard drive was scrapped onsite by the customer.This is normal protocol so that phi (protected health information) would remain secure.(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) 2017, a customer reported to merge healthcare that the hemo monitor froze during a procedure in the site's ep lab 1.The hemo monitor automatically rebooted causing a loss of physiological monitoring.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 once the hemo monitor rebooted.(b)(4).
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