One swan ganz module was received for product evaluation.The suspect product was connected to a known good working hemosphere instrument for analysis and testing.The system verification test was performed and left to run for over 30 minutes.The co values remained within appropriate parameters.There were no error messages observed.A visual inspection was performed and there was no physical damage identified.There was no defect found.The reported event was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.There was no inappropriate patient treatment administered.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.It is unknown if user or procedural factors contributed to the stated event.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.The hemosphere instrument (hem1), that was linked with this sg module, submission number is 2015691-2019-03069.The hem1 instrument was not returned for evaluation as the exact product used with this sg module is unknown.There are no product results available.
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