The customer declined the option to have their glidescope core smart cable returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Based on communication with the customer, the likely cause of the reported issue was isolated to just the glidescope core smart cable.Review of complaint history for the reported smart cable serial number "(b)(4)" did not identify any previous complaints reported to verathon.Trending analysis for the glidescope core smart cables does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.Verathon recommended the customer replace their glidescope core smart cable as there are currently no repairs available for this device.Corrective action is not required at this time.Verathon will continue to monitor for trends.
|
The customer reported that during a patient procedure, using a glidescope core smart cable, the image was grainy, and would also intermittently disappear when the cable was manipulated.No delay in the procedure, use of a backup device, or harm to the patient was reported.
|