|
Model Number 0800-0543 |
Device Problems
Erratic or Intermittent Display (1182); No Display/Image (1183)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The customer declined the option to have their glidescope spectrum 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 spectrum smart cable.Review of complaint history for the reported smart cable serial number (b)(4) did not identify any previous complaints.Trending analysis for the glidescope spectrum smart cable 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 purchase a replacement glidescope spectrum smart cable as their smart cable likely needed to be replaced, and there are currently no repairs available for this device.Corrective action is not required at this time.Verathon will continue to monitor for trends.
|
|
Event Description
|
The customer reported that during a patient procedure, using a glidescope spectrum smart cable, the image intermittently disappeared when the cable's hdmi connector was manipulated.The procedure was completed using a backup glidescope device, which was made available in an unspecified amount of time.No harm to the patient was reported.
|
|
Search Alerts/Recalls
|
|
|