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 problems were experienced in the middle of a procedure after active monitoring and sedation had been initiated.Subsequently, the hemo monitor was rebooted that resulted in a loss of patient monitoring.The delay was ~10-15 minutes while the hemo system rebooted.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the customer reported that the procedure was completed successfully once the hemo monitor was rebooted.(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 01jan2017.During troubleshooting efforts between the customer and merge technical support, the customer reported that the hemo monitor was rebooted in the site's cath lab 2 and this corrected the issue.However, the customer called in two (2) subsequent times to report a similar issue in the same lab.Reference 2183926-2016-0000826 and 2183926-2016-00829.During this occurrence, the customer was shipped a replacement hemo monitor (reference rma #(b)(4)) on 09dec2016; however it was not needed so the customer returned it unused to merge healthcare on 20feb2017.The unit was evaluated and it was confirmed that the unit was not used and the same serial number shipped to the customer was the same one returned.A review of the customer's hemo case management within merge healthcare's internal database on 30apr2018 confirmed that there have been no further issues reported by the customer to merge healthcare concerning an issue requiring a reboot of the hemo monitor since the last occurrences cited above.Device labeling, hemo-6373 v10 user manual, addresses the potential for a loose cable connection 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." no further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious injury assessment to a 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: 10 - actual device evaluated results code #1: 3247 unused device returned in sterile packaging.Results code #2: 3213 interoperability problem (a problem with the mechanical, electrical, or communication interface between two or more separate devices or components).Conclusions code: 13 device difficult to operate.H10 - indication of additional manufacturer information is contained in this follow-up report.
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