It was reported that during patient monitoring with the hemosphere instrument (hem1) in use, there was a difference in the blood pressure readings between the hem1 and the bedside monitor.The smart pressure cable was moved from port 1 to port 2 on the hem1 and then issue was resolved and the readings correlated.The issue was isolated to port 1 on the hem1.There were no error messages displayed.The waveform was not abnormal.The patient demographic information was requested; however, the hospital will not release it.There was no inappropriate treatment administered.There was no patient harm or injury.
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One hemosphere instrument, hem1, was received for evaluation.The unit was tested per the system level verification test with a known good working pressure cable and pressure simulator.Both cable ports were tested and both ports were found to be functioning normally.There were no abnormalities observed.The diagnostic logs were reviewed and there was a fault message of "co-arterial waveform compromised" that was displayed during the timeline of the event.Analyzing the log data, the pressure cable was first used on port 1 and it was observed that an attempt to zero the pressure cable at 5am on oct 31 was performed.The pressure cable was exchanged from port 1 to port 2 around 6:27am.While the ew representative's photos showed the monitor¿s readings aligned with the data in the diagnostic logs, the port change timing did not align.The picture shows the supposed port 2 readings at 6:18 am on oct.31, but the diagnostic logs show the port was switched at 6:27 am.In analyzing the readings in the minutes before and after the port change, the data did not suggest a shift in the trends between the 2 ports.Additionally, the system level verification test that was performed was found that the unit was functioning normally.The reported event could not be confirmed.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.No further actions will be taken at this time.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of the monthly review.
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