Model Number 4100062000 |
Device Problem
Overheating of Device (1437)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/17/2021 |
Event Type
malfunction
|
Event Description
|
The user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
|
|
Manufacturer Narrative
|
Update: d9, h3, h6.Device evaluation: follow-up report submitted to document device evaluation results.
|
|
Event Description
|
The user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
|
|
Search Alerts/Recalls
|
|