A supplemental mdr is being submitted due to product evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.One hemcsm10 was received for product evaluation.The suspect hemcsm10 was connected to a known working hem1 hot mock-up system.The hemcsm10 caused no errors.It was also able to obtain normal blood pressure readings and waveform.The hemcsm10 was ran for 1 hour and the readings remained stable.No damage was found.There was no defect.
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