|
|
| Model Number |
0570-0382 |
| Medical Device Problem Codes |
Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
|
| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
|
| Date of Event |
11/10/2025
|
|
Type of Reportable Event
|
Malfunction
|
|
Event or Problem Description
|
|
A customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the video on the connected glidescope core 10-inch monitor intermittently fails, displaying a disconnected message before returning with a split, fuzzy image.The customer further reported that it is necessary to wiggle or apply pressure to the glidescope core smart cable during use to restore the video display.No delay in the procedure, use of a backup device, or harm to the patient was reported.
|
| |
|
Additional Manufacturer Narrative
|
|
Upon review of the device history for the video baton serial number (b)(6), it was determined that the device was manufactured on november 25, 2021, and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).Since the device was not returned to verathon for evaluation at this time, the cause of the reported issue is unknown; however, it is likely that the age of the device, four (4) years, may have caused or contributed to the event.The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
|
| |
|
Search Alerts/Recalls
|
|
|