Merge hemodynamics displays, 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.The replacement vga splitter from 2183926-2020-00023 has the same issue after installation attempt on (b)(6) 2020.This was an out of box failure so there was no patient involvement.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).
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This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 07/13/2020.The rma was processed on 2020aug26 by merge healthcare installation.The hardware investigation was performed by a whi implementation product specialist on 2020sep08 who noted the following: investigated the issue.Did not find an issue with excessive heat build up.The issue is a faulty or damaged connector on the power adapter.An intermittent connection could possibly cause heat build up if left for an extended period of time.The connection is intermittent, power to the splitter is lost and the green power indicator on the power adapter goes out when the connector or the wire to the connector is moved or disturbed.When the splitter is connected to a known good power adapter then no issue is observed.(test power adapter me testing area was used as a known good source).No further action is required.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.There were no customer reports of this issue.Revised information contained in this supplemental report includes the following: g3 - date new information received by manufacturer; g6 - indication that this is follow-up report 001; h1 - indication of malfunction as reportable event; h2 - indication of additional information; h3 - indication that device evaluated by manufacturer; h6 - evaluation codes: health effect - clinical code 4582 no clinical symptom/sign, health effect - impact code 2199 no health consequences or impact, medical device problem code 1435 no device output, component code 423 cable, electrical, type of investigation 10 testing of actual/suspected device.Investigation findings 4203 the performance of an electrical or electronic component was found to be inadequate.Investigation conclusions 4307 cause traced to component failure h10 - indication of additional manufacturer information is contained in this follow-up report.
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