A spacelabs field service engineer performed an investigation of the service logs and confirmed the reported complaint.Performance checks were completed and operational status verified.During the display of the failed state for this device, the patient can still be hand ventilated with anesthesia gases and oxygen, regulators still register and an alarm sounds continuously.These devices are constantly attended and the licensed clinicians in attendance have the means from the device to maintain patient safety.Consequently, there is not risk for serious patient harm and this is not a reportable event.However, spacelabs is filing reports of similar issues as requested by the fda letter dated october 10, 2017.
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