|
Model Number C-VH-3010 |
Device Problems
Crack (1135); Failure to Deliver Energy (1211)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/16/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device not returned.
|
|
Event Description
|
The hospital reported that the t.W.Power supply had no power; old; not working and looks cracked.It was discovered during sterile processing.No injury was reported.
|
|
Manufacturer Narrative
|
Trackwise # (b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.The product is not returning.A serial number was not provided and the specific product serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|
|
|