During troubleshooting efforts between the customer and merge technical support, the customer stated that when the hemo monitor froze, the pdm (patient data module) would buzz.The medical staff checked the +5v and +12v led's and both were lit when the pdm buzzed.The hemo monitor was rebooted a couple of times and eventually the hemo system started back up on its own.The medical staff confirmed to merge technical support that all cable connections were properly connected.Replacement hardware (rma #12714), a hemo monitor pc fru t3610, was shipped to the customer on 13jul2017.The faulty unit was received by merge healthcare on 18jul2017 for evaluation.The results showed that the unit contained an older serial card and was subsequently replaced with a lava brand serial card.The hard drive was also replaced and it passed all diagnostics testing.The unit was reloaded with software, it ran for five (5) days without issue, and was then sent to service stock.It was noted that the customer retained the unit's old hard drive so that phi (protected health information) would remain secure.It was found that the customer's reported problem is related to a previous internal investigation conducted by merge healthcare (hemo-6542).The problem occurs due to the serial port interface contained within the hemo pc that causes intermittent connection with the pdm.The resolution is to replace the older serial cards with lava brand serial cards.(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 about sixty (60) minutes into a procedure and continued to freeze every fifteen (15) minutes thereafter.The medical staff successfully completed the procedure using third party monitoring.The patient's data was manually charted and then added into the hemodynamics software for study report creation.With merge hemo not capturing physiological data, there is a potential for delay of treatment that could result in harm to the patient.However, the procedure was completed successfully using third party monitoring.Reference complaint-(b)(4).
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