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 and client pc froze in the middle of a procedure after active monitoring and sedation had been initiated.Subsequently, both units were rebooted that resulted in a loss of patient monitoring.It was reported that the delay was a "few 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 procedure was completed successfully once the hemo system 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 04feb2017.Merge technical support contacted the customer to schedule time for remote access of their cath lab to investigate the reported issue.However, the customer did not respond to attempts to troubleshoot so the investigation is inconclusive and the complaint was unable to be confirmed.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).No further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious impact to a patient, and the customer's non-response for troubleshooting assistance from merge technical support.Information contained in this supplemental report includes the following: device availability (device not available for evaluation).Mfr site - report source - updated contact office - name/address.Date new information received by manufacturer (supplemental report creation date).Indication that this is follow-up report 001.Indication of malfunction as reportable event.Indication of additional information.Indication that the device not evaluated by manufacturer.Evaluation codes: method: 3323 - no testing methods performed.Results: 3221 - no results available since no evaluation performed (for use when no methods were performed and therefore no results will be obtained.) conclusions: 67 - unable to confirm complaint.Indication of additional manufacturer information is contained in this follow-up report.
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