MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
|
Back to Search Results |
|
Model Number BI70002000 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/09/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information regarding an imaging device being used intra/peri-operatively of a cervical spine procedure.It was reported that during a case the pendant would be cycle booting.The site reports that the pendant would boot normally then would intermittently cycle and say that it is booting.The imaging system was still used for the case however, the site would have to wait for it to clear booting in order to shoot the x-ray.There was a less than 1-hour delay to the procedure and no impact on patient outcome.Additional information was received.It was suspected that the issue was caused by a loose connection.
|
|
Search Alerts/Recalls
|
|
|