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 the hemo monitor had to be rebooted during a procedure involving a stemi patient that resulted in approximately a 10-15 minute delay.With merge hemo not presenting physiological data during treatment, there is a potential for harm to the patient due to delay in treatment.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted.Reference complaint number (b)(4).
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This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 05sep2016.During troubleshooting activities between merge technical support and the customer, it was found that the customer rebooted the hemo monitor pc twice but the problem persisted.Merge technical support advised the customer to check all connections at the video splitter and to make sure the unit had power.In follow up communication on 07oct2016, the customer confirmed that the hemo monitor in the site's cath lab 2 was working correctly.Information on the site's resolution for the connection issue was not divulged to merge healthcare.To resolve the issue at the time it is recognized, the users are instructed to check the cabling between the client pc and the hemo monitor.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Device labeling, (b)(4) v10 user manual, addresses the potential for such an occurrence in the troubleshooting section with statements such as, "problem: there is no communication between hemo monitor pc and client.Resolution: check that the crossover cable from the client to the hemo monitor is plugged in properly and lights are on.Reboot the hemo monitor pc.Exit and reopen the study.Answer yes to "is patient still being monitored." check that the client is properly configured to use the hemo monitor pc (in system config).If none of these work, contact technical support." additionally, in the general equipment care section it states, "inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required." for this reason, conclusion code 51 (maintenance deficiency) was used.No further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious injury assessment to the patient, and the instructions provided to the user on what to do if this situation were to occur.Revised information contained in this supplemental report includes the following: h6 - evaluation codes: methods code: 20 interoperability evaluation (testing devices for problems with the mechanical, electrical, or communication interface between two or more separate devices or components).Results code: 423 cable.Conclusions code: 51 maintenance deficiency (device problems that result from improper routine or preventative maintenance).H10 - indication of additional manufacturer information is contained in this follow-up report.
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