|
Model Number 10590000 |
Device Problems
Component Missing (2306); Separation Problem (4043)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/11/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Siemens has initiated a technical investigation of the reported event.The root cause has not been identified.A supplemental report will be submitted upon the completion of the investigation.
|
|
Event Description
|
It was reported to siemens that during the table movement of the somatom definition edge nexaris system (combination of ct scanner and angio c-arm), the tabletop dislocated from the table support due to missing screws.At the time of the event, a ct phantom was placed on the table and there was no patient involvement.No injury to the user or others was reported.The system had been recently installed and the siemens application support specialist was onsite to train the customer.This event is being reported with an abundance of caution.
|
|
Manufacturer Narrative
|
Siemens completed a technical investigation of the reported event.An isolated working error during installation was confirmed by the technical investigator (root cause).The installation instruction (document ct00-000.812.01) has been checked and was found appropriate.The worker was identified and trained again.Since no systematic issue has been identified, no preventive action has been initiated.
|
|
Search Alerts/Recalls
|
|
|